FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK
MDR report key: 3150284
·
Received June 6, 2013
Report
- Report Number
- 9611594-2013-00062
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 7, 2013
- Manufacturer
- AVENT S. DE R.L. DE C.V.
- Product Code
- HEB
- PMA / PMN Number
- K113036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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
THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT HER TAMPON UNRAVELED UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251136 | U BY KOTEX CLICK | TAMPON | HEB | AVENT S. DE R.L. DE C.V. | AA222801B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |