FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX SLEEK
MDR report key: 3223395
·
Received July 12, 2013
Report
- Report Number
- 2381757-2013-00028
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 12, 2013
- Report Date
- June 13, 2013
- Manufacturer
- KIMBERLY-CLARK CORPORATION - CONWAY MILL
- Product Code
- HEB
- PMA / PMN Number
- K112635
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE CONSUMER STATED THAT TWO TAMPONS CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE FEELS THAT SHE WAS ABLE TO REMOVE THE REMAINING PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324249 | U BY KOTEX SLEEK | TAMPON | HEB | KIMBERLY-CLARK CORPORATION - CONWAY MILL | REGULAR | AC220066X148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |