MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-08 for KOTEX manufactured by Kimberlyclark.
[4894089]
I have been using pads and pantiliners for the past 10 years and i have always had issues with pain, burning, itching, and bad rashes when using any major pad or pantiliner product such as always and kotex. I finally did my research after the pain and burning got so bad it hurt to walk. I learned that there is sulfur in the pads and pantiliners and i am allergic to it. My doctor confirmed this and i have since stopped using this products and found all organic ones with no sulfur whatsoever and have been fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038151 |
| MDR Report Key | 4085152 |
| Date Received | 2014-09-08 |
| Date of Report | 2014-09-08 |
| Date of Event | 2014-08-10 |
| Date Added to Maude | 2014-09-15 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOTEX |
| Generic Name | PANTILINERS |
| Product Code | HHD |
| Date Received | 2014-09-08 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLYCLARK |
| Brand Name | ALWAYS |
| Generic Name | PAD |
| Product Code | HHD |
| Date Received | 2014-09-08 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PROCTOR & GAMBLE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-09-08 |