MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for POISE PADS LONG LENGTH, MAXIMUM ABSORBENCY manufactured by Kimberly-clark Corporation - Conway Mill.
[143452487]
After using poise pads long length, maximum protection (upc (b)(4)), i developed intense burning and pain in my perineal area. I had severe pain when urinating and it felt like my labia were literally on fire. This is the 2nd pad that i have used and it happened with the 1st pad but i didn't think anything about the possibility of the pad causing the issue. With the 2nd pad, the intense burning and pain was beyond imaginable. I'm not sure what chemicals kimberly-clark uses to make the pads or what link is used for the purple decorations on the absorbent pad itself but it is very irritating. It literally feels like someone is holding a burning candle to my private parts. Please investigate these pads as they are very irritating and painful to wear. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086224 |
| MDR Report Key | 8556688 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-24 |
| Date of Event | 2016-04-24 |
| Date Added to Maude | 2019-04-26 |
| 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 PADS LONG LENGTH, MAXIMUM ABSORBENCY |
| Generic Name | GARMENT PROTECTIVE FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-04-25 |
| Lot Number | UPC 036000195705 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Brand Name | POISE PADS LONG LENGTH, MAXIMUM ABSORBENCY |
| Generic Name | GARMENT PROTECTIVE FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-04-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-25 |