MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for POISE PADS LONG LENGTH manufactured by Kimberly Clark Corp.
[114745126]
Have been using poise incontinence pads. Developed extremely itchy rash where pad touches - lower abdomen to above anus (long length pads). Thought at first it was a vaginal yeast infection, but i had no itching inside vagina; only externally. Intense itching. Finally stopped using pads. The next day, itching started decreasing. Looked it up on the internet. Complaints going back to 2014. Is this product over the counter? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078481 |
| MDR Report Key | 7705777 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-18 |
| Date of Event | 2016-03-01 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| Generic Name | GARMENT, PROTECTIVE FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-07-19 |
| 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 | 2018-07-19 |