MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for KOTEX manufactured by Kimberly - Clark Corp. Conway Mill.
[141318824]
Kotex daily liners are coming apart with each use which is dangerous and unsanitary. Please see the complaints and pictures on their own comments page and they aren't addressing 'itz'. I bought two boxes so i still have them. I contacted kotex without any response. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085637 |
| MDR Report Key | 8491823 |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-01 |
| Date Added to Maude | 2019-04-08 |
| 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 | 3 |
| Brand Name | KOTEX |
| Generic Name | PAD, MENSTRUAL |
| Product Code | HHD |
| Date Received | 2019-04-05 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY - CLARK CORP. CONWAY MILL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-05 |