MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for POISE MICROLINERS manufactured by Kimberly Clark Corp..
[132234174]
I used poise pads in the purple box, pantiliners, after anal polyp surgery to catch any spotting from my incision. After two days' use, i noticed that i had more than a little bleeding. My entire rectal, perineum area was red and itchy and inflamed. It was quite painful. Upon stopping the use of the pads and treating the area with cortisone ointment, zinc oxide, and bacitracin ointment, the inflammation and itching and bleeding ceased. I will never use the poise pantiliner products again as something in the product caused much irritation to my nether regions. Is the product over-the-counter? Yes; did the problem stop after the person reduced the dose or stopped taking or using the product? Yes; did the product problem return if the person started taking or using the product again? Yes; date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082767 |
| MDR Report Key | 8212612 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-30 |
| Date of Event | 2018-12-28 |
| Date Added to Maude | 2019-01-03 |
| 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 MICROLINERS |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-01-02 |
| Lot Number | BJ823201X0028NO |
| 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. Other | 2019-01-02 |