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.
4 linked reportsInjury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2020-05 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-12 | 0 | 1 |
| 2023-07 | 0 | 1 |
| 2024-12 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-08 | 2 | 2 |
| 2025-11 | 2 | 2 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-30 | 2280705-2025-01788 | Injury | Available | exact di |
| 2025-08-21 | 2280705-2025-01427 | Injury | Available | exact di |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
Predicate lineage
K895640
Cited as predicate by: K120249
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-12 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2024-07-18 | NAI | No action indicated | Church & Dwight Canada Corp. | 0 |
| 2023-08-08 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2022-07-15 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2017-10-31 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 1 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-03-13 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-08-24 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-02-17 | NAI | No action indicated | Church & Dwight Co., Inc. | 0 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2010-07-08 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 3 |
Similar devices
- "ONE ""Fun Mix" GLOBAL PROTECTION CORP.
- "ONE ""Popular Mix" GLOBAL PROTECTION CORP.
- "ONE ""Sensitive Mix" GLOBAL PROTECTION CORP.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Aloe Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® CONDOMS OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- 004® ZERO ZERO FOUR® Condoms OKAMOTO USA, INC.
- ADAM & EVE SURETEX LIMITED - BRANCH
Select up to two to place side-by-side with this device.