FDA Adverse Event
Malfunction
Summary report: N
KOTEX NATURAL BALANCE
MDR report key: 3782025
·
Received April 30, 2014
Report
- Report Number
- 2381757-2014-00036
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- January 1, 2014
- Report Date
- April 4, 2014
- Manufacturer
- KIMBERLY-CLARK CORPORATION - CONWAY MILL
- Product Code
- HEB
- PMA / PMN Number
- K896994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A DOCUMENT AND RECORDS REVIEW WAS PERFORMED OF THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDED: MANUFACTURING, ENVIRONMENTAL RECORDS, MICRO, QA AUDIT, OPERATOR ENTRY, OPERATOR AND PRODUCTION LINE LOGS, RAW MATERIAL, FINISHED PRODUCT TESTING AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE. CONSUMER RETURNED UNUSED PRODUCT ON (B)(4) 2014 AND EVALUATION IS UNDERWAY. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.
Description of Event or Problem · 1
THE CONSUMER STATED THAT HER TAMPON CONTAINED A BLACK SUBSTANCE WHICH APPEARED TO BE MOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260881 | KOTEX NATURAL BALANCE | TAMPON | HEB | KIMBERLY-CLARK CORPORATION - CONWAY MILL | REGULAR | AC009826X0252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |