FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLINCK
MDR report key: 3232346
·
Received December 11, 2012
Report
- Report Number
- 9611594-2012-00153
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 14, 2012
- Manufacturer
- AVENT SA DE R.L. DE C.V.
- Product Code
- HEB
- PMA / PMN Number
- K113036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MFG QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. COMPLAINT SAMPLE WAS RETURNED AND PRODUCT EVAL IS UNDERWAY. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.
Description of Event or Problem · 1
THE CONSUMER INDICATED THAT HER TAMPON CAME APART AND TAMPON PIECES REMAINED INSIDE OF HER. SHE STATED THAT UPON REMOVAL OF THE TAMPON SHREDDED INTO PIECES. SHE BELIEVES THAT SHE WAS ABLE TO REMOVE ALL REMAINING PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U BY KOTEX CLINCK | TAMPON | HEB | AVENT SA DE R.L. DE C.V. | SUPER | AA225701A0956 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |