FDA Adverse Event
Summary report: N
KOTEX
MDR report key: 8491823
·
Received April 5, 2019
Report
- Report Number
- MW5085637
- Date Received
- April 5, 2019
- Date of Event
- March 1, 2019
- Report Date
- March 27, 2019
- Manufacturer
- KIMBERLY - CLARK CORP. CONWAY MILL
- Product Code
- HHD
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282607 | KOTEX | PAD, MENSTRUAL | HHD | KIMBERLY - CLARK CORP. CONWAY MILL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |