MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for POISE LINERS manufactured by Kimberly-clark Corp..
[110637436]
Several days of burning and discomfort followed by severe peripheral pain landing me in emergency room (er). Physician unable to determine cause. Next day seen by ob/gyn and due to severity of pain pudendal nerve block administered but results only lasted two days. Did not connect it to wearing poise light incontinency pads until today when realized burning only happened with reintroduction of pads. Will never use again and if the pudendal nerve is damaged i will seek legal action.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077698 |
| MDR Report Key | 7582183 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-31 |
| Date Added to Maude | 2018-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POISE LINERS |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-06-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-06-07 |