L.TAMPONSORGCOTTONCOMPAK
Report
- Report Number
- 1219109-2022-00501
- Event Type
- Malfunction
- Date Received
- December 22, 2022
- Report Date
- February 1, 2023
- Manufacturer
- ONTEX HYGIENEARTIKEL GMBH
- Product Code
- HEB
- PMA / PMN Number
- K162746
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS IN PROGRESS FOR THE CONFIRMED ONTEX LOT CODE ON JANUARY 9, 2023.
THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
BALL OF COTTON STUCK INSIDE VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. SMELL DOWN THERE- VAGINA [VAGINAL ODOUR]. BALL OF COTTON WITH BLOOD CAME OUT OF MY VAGINA....STUCK INSIDE FOR LIKE A WEEK [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT A BALL OF COTTON CAME OUT OF HER VAGINA THAT HAD BEEN STUCK INSIDE. NO SERIOUS INJURY WAS REPORTED. ON 09-JAN-2023: PRODUCT IDENTIFIED AS ONTEX L. FROM LOT CODE PROVIDED. PLEASE SEE REPORT 1216894-2023-00002 REGARDING THE TAMPON PRODUCT THAT WAS NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.
BALL OF COTTON STUCK INSIDE VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. SMELL DOWN THERE- VAGINA [VAGINAL ODOUR]. BALL OF COTTON WITH BLOOD CAME OUT OF MY VAGINA....STUCK INSIDE FOR LIKE A WEEK [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT A BALL OF COTTON CAME OUT OF HER VAGINA THAT HAD BEEN STUCK INSIDE. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1632090 | L.TAMPONSORGCOTTONCOMPAK | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | ONTEX HYGIENEARTIKEL GMBH | 1851177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Female |