MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-12 for KOTEX manufactured by Kimberly-clark Global Sales.
[17528470]
Ms (b)(6) experienced an allergic reaction to kotex panty liner and pad product samples that she rec'd in the mail. Ms (b)(6) stated that she used the free samples, at which time, approximately 8-12 hours later, she began to experience discomforting symptoms of itching, swelling, and burning of the labia genitalia area. Consumer did consult her ob/gyn who examined her on (b)(6) 2010, and diagnosed her symptoms as an allergic reaction, and prescribed her "prednisone" for her symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016837 |
| MDR Report Key | 1777174 |
| Date Received | 2010-07-12 |
| Date of Report | 2010-05-28 |
| Date of Event | 2010-05-17 |
| Date Added to Maude | 2010-08-03 |
| 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 | 0 |
| 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 | U BY KOTEX (SANITARY NAPKIN) |
| Product Code | HHD |
| Date Received | 2010-07-12 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK GLOBAL SALES |
| Manufacturer Address | 351 PHELPS DR IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-12 |