FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK TAMPONS
MDR report key: 2823706
·
Received January 10, 2011
Report
- Report Number
- 3007303617-2011-00001
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 1, 2010
- Report Date
- December 15, 2010
- Manufacturer
- QINGDAO P&B CO. LTD
- Product Code
- HEB
- PMA / PMN Number
- K091749
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT CODE WAS NOT PROVIDED. CONSUMER DID NOT RETURN PRODUCT FOR EVAL.
Description of Event or Problem · 1
CONSUMER WAS REMOVING A TAMPON AND THE STRING CAME OUT. WHEN THE CUSTOMER REMOVED THE PLEDGET IT CAME APART IN PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U BY KOTEX CLICK TAMPONS | HEB - UNSCENTED MENSTRUAL TAMPON | HEB | QINGDAO P&B CO. LTD | SUPER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |