Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
37 linked reportsMalfunction 27Injury 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.5 |
| 2019-02 | 0 | 1.13 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 2 | 1.57 |
| 2019-05 | 2 | 1.83 |
| 2019-06 | 1 | 1 |
| 2019-07 | 0 | 1.6 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1.6 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 1 | 1.58 |
| 2020-01 | 0 | 1.25 |
| 2020-02 | 0 | 2.43 |
| 2020-03 | 0 | 1.63 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1 |
| 2020-06 | 0 | 1.4 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1.67 |
| 2020-10 | 0 | 1.75 |
| 2020-11 | 0 | 1.67 |
| 2020-12 | 1 | 1.33 |
| 2021-01 | 2 | 1.5 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 1.22 |
| 2021-05 | 0 | 1.78 |
| 2021-06 | 0 | 1.67 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.14 |
| 2021-09 | 0 | 1.25 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1.86 |
| 2022-01 | 0 | 1.33 |
| 2022-02 | 0 | 1.17 |
| 2022-03 | 1 | 2 |
| 2022-04 | 0 | 1.91 |
| 2022-05 | 0 | 1.71 |
| 2022-06 | 0 | 5.25 |
| 2022-07 | 0 | 1.71 |
| 2022-08 | 0 | 6 |
| 2022-09 | 0 | 2.38 |
| 2022-10 | 0 | 3.33 |
| 2022-11 | 0 | 2.67 |
| 2022-12 | 0 | 4.25 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 2.5 |
| 2023-03 | 0 | 2.71 |
| 2023-04 | 0 | 2.14 |
| 2023-05 | 0 | 3.5 |
| 2023-06 | 0 | 5 |
| 2023-07 | 0 | 1.71 |
| 2023-08 | 0 | 3.5 |
| 2023-09 | 0 | 3.4 |
| 2023-10 | 2 | 2.67 |
| 2023-11 | 0 | 1.83 |
| 2023-12 | 0 | 6 |
| 2024-01 | 0 | 6.67 |
| 2024-02 | 3 | 4 |
| 2024-03 | 0 | 6 |
| 2024-04 | 0 | 2.75 |
| 2024-05 | 0 | 4.33 |
| 2024-06 | 0 | 3.67 |
| 2024-07 | 0 | 5 |
| 2024-08 | 0 | 2 |
| 2024-09 | 3 | 2.5 |
| 2024-10 | 0 | 1 |
| 2024-11 | 9 | 5.8 |
| 2024-12 | 3 | 2 |
| 2025-01 | 0 | 2.5 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 3 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 4 |
| 2025-06 | 0 | 2.5 |
| 2025-07 | 0 | 3.5 |
| 2025-08 | 0 | 2.33 |
| 2025-09 | 0 | 1 |
| 2025-10 | 3 | 2.5 |
| 2025-11 | 2 | 1.5 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 2.33 |
| 2026-02 | 0 | 2.5 |
| 2026-03 | 2 | 2.5 |
| 2026-04 | 0 | 5 |
| 2026-05 | 0 | 2.25 |
| 2026-06 | 0 | 3.33 |
Failure-mode summaryAI-generated
37 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-07-08 | Z-2364-2019 | Class II | Terminated | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.Distribution: Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & United Kingdom. | 49813 | clearance family |
| 2013-05-01 | Z-1397-2015 | Class II | Terminated | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specificationDistribution: Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES | 4,807,566 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-18 | 24625822 | Malfunction | Available | model number |
| 2025-11-07 | 23496115 | Malfunction | Available | model number |
| 2025-10-16 | 1216677-2025-00043 | Injury | Available | exact di |
| 2024-12-12 | 1216677-2024-00067 | Injury | Available | exact di |
| 2024-11-27 | 20795343 | Malfunction | Available | model number |
| 2024-11-27 | 20795342 | Malfunction | Available | model number |
| 2024-11-15 | 1216677-2024-00063 | Malfunction | Available | exact di |
| 2024-11-05 | 20609117 | Malfunction | Available | model number |
| 2024-09-16 | 20223607 | Malfunction | Available | exact di |
| 2024-02-28 | 1216677-2024-00005 | Injury | Available | exact di |
| 2023-10-26 | 1216677-2023-00142 | Malfunction | Available | exact di |
| 2022-03-10 | 1216677-2022-00061 | Malfunction | Available | model number |
| 2021-01-05 | 11116251 | Malfunction | Available | model number |
| 2020-12-04 | 10945540 | Malfunction | Available | model number |
| 2019-12-20 | 1216677-2019-00322 | Injury | Available | model number |
Showing the most recent 20 of 37 linked reports.
Showing 1–15 of 20
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-02-01 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-05-16 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2023-04-27 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 5 |
| 2022-12-15 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2021-07-15 | VAI | Voluntary action indicated | CooperSurgical, Inc. | 4 |
| 2019-08-01 | NAI | No action indicated | CooperSurgical, Inc. | 2 |
| 2018-05-02 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-12-07 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2017-05-04 | NAI | No action indicated | Lone Star Medical Products, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2016-03-31 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2015-12-10 | NAI | No action indicated | Leisegang Feinmechanick-Optik GmbH | 0 |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2015-06-09 | WL | Warning Letter | CooperSurgical, Inc. | — |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-17 | OAI | Official action indicated | CooperSurgical, Inc. | 8 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-12-01 | NAI | No action indicated | CooperSurgical, Inc. | 0 |
| 2014-09-23 | VAI | Voluntary action indicated | Lone Star Medical Products, Inc. | 0 |
| 2013-04-25 | WL | Warning Letter | Lone Star Medical Products, Inc. | — |
| 2012-07-11 | WL | Warning Letter | Leisegang Feinmechanick-Optik GmbH | — |
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