FDA Adverse Event
Malfunction
Summary report: N
KOTEX NATURAL BALANCE
MDR report key: 3151390
·
Received June 7, 2013
Report
- Report Number
- 2381757-2013-00022
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 13, 2013
- Manufacturer
- KIMBERLY-CLARK CORPORATION - CONWAY MILL
- Product Code
- HEB
- PMA / PMN Number
- K896994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 RETURNED UNUSED PRODUCT ON (B)(4) 2013 AND EVALUATION IS PLANNED.
Description of Event or Problem · 1
THE CONSUMER STATED THAT SEVERAL TAMPONS CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE VISITED HER DOCTOR ON (B)(6) 2013 AND HE RETRIEVED A PIECE OF THE TAMPON. SHE WAS DIAGNOSED WITH A YEAST INFECTION AND PRESCRIBED FLUCONAZOLE AND CLINDAMYCIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253362 | KOTEX NATURAL BALANCE | TAMPON | HEB | KIMBERLY-CLARK CORPORATION - CONWAY MILL | REGULAR | AC307221X0528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |