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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-05 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2023-07 | 2 | 2 |
| 2025-01 | 0 | 2 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-07-11 | 2280705-2023-01038 | Injury | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
- 510(k)K123427Substantially equivalent (SESE) · 2013-06-28clearance family
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
- LubeLife - Strawberry - Lubricant 8oz/240mL - JP CC Wellness LLC
- Lubelife - Warming - 8oz - International CC Wellness LLC
- NO FORGET LOVE Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
- NO FORGET LOVE Water Soluble Personal Lubricant Shenzhen Yongquan Medical Devices Co., Ltd.
Select up to two to place side-by-side with this device.