L.TAMPONSORGCOTTONCOMPAKREGNOR
Report
- Report Number
- 1219109-2021-00440
- Event Type
- Malfunction
- Date Received
- December 9, 2021
- Report Date
- November 10, 2021
- 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
THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
UNABLE TO REMOVE - TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. UNABLE TO REMOVE TAMPON [COMPLICATION OF DEVICE REMOVAL]. STRING WAS NOT SECURE - CAME OUT WITHOUT TAMPON [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRING WAS NOT SECURE AND CAME OUT WITHOUT THE TAMPON, NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP: 07-DEC-2021: PRODUCT IDENTIFIED AS ONTEX L. VIA PROVIDED PHOTO. PLEASE SEE REPORT 1216894-2022-00002 REGARDING THE ACTUAL PRODUCT INVOLVED THAT WAS NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.
UNABLE TO REMOVE - TAMPON [FOREIGN BODY IN REPRODUCTIVE TRACT]. UNABLE TO REMOVE TAMPON [COMPLICATION OF DEVICE REMOVAL]. STRING WAS NOT SECURE - CAME OUT WITHOUT TAMPON [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON STRING WAS NOT SECURE AND CAME OUT WITHOUT THE TAMPON, NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1865516 | L.TAMPONSORGCOTTONCOMPAKREGNOR | TAMPON, MENSTRUAL, UNSCENTED` | HEB | ONTEX HYGIENEARTIKEL GMBH | 13562/5891 05:49 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |