FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
MDR report key: 5238965
·
Received November 20, 2015
Report
- Report Number
- 3011112444-2015-00025
- Event Type
- Malfunction
- Date Received
- November 20, 2015
- Date of Event
- October 27, 2015
- Report Date
- October 27, 2015
- 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. THREE COMPANION SAMPLES WERE RETURNED A PRODUCT EVALUATION DID NOT OBSERVE ANY DEFECTS OR ABNORMALITIES. 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
CONSUMER STATED THAT 2 OF THE TAMPONS SPLIT WHEN SHE WAS REMOVING THEM. THE CONSUMER WENT TO THE ER WHERE 2 TAMPON PIECES WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770442 | 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 | SUPER | AA513801A1518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |