MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for TAMPON U BY KOTEX manufactured by Kimberly Clark Corp..
[141915738]
A u by kotex tampon came apart as i removed it and pieces were left behind, inside of me. I've never noticed this issue before and looking it up have come to realize there were other multiple reports and issues. The box of tampons was purchased more recently and i am unsure i can get a refund. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085811 |
| MDR Report Key | 8509099 |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-09 |
| Date Added to Maude | 2019-04-12 |
| 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 | TAMPON U BY KOTEX |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2019-04-11 |
| 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 | 2019-04-11 |