FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
MDR report key: 5640300
·
Received May 9, 2016
Report
- Report Number
- 3011112444-2016-00006
- Event Type
- Malfunction
- Date Received
- May 9, 2016
- Date of Event
- April 8, 2016
- Report Date
- April 11, 2016
- Manufacturer
- K-C AFC MANUFACTURING, S. DE R.L. DE C.V (NUEVO NOGALES
- Product Code
- HEB
- PMA / PMN Number
- PK113036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, 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. COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.
Description of Event or Problem · 1
WHEN REMOVING THE TAMPON THE CONSUMER STATED IT BROKE IN HALF AND SHE REMOVED THE PIECES. SHE THEN WENT TO HER DOCTOR AND HE CONFIRMED THAT IT WAS ALL REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297034 | U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB | TAMPON, MENSTRUAL, UNSCENTED | HEB | K-C AFC MANUFACTURING, S. DE R.L. DE C.V (NUEVO NOGALES | REGULAR | AA534001A0825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |