L.TAMPONSORGCOTTONCOMPAKSUPER
Report
- Report Number
- 1219109-2022-00092
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Report Date
- February 8, 2022
- 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.
A PRODUCT INVESTIGATION IS IN PROGRESS.
TRYING TO DIG THE PIECES/FIBERS OUT THIS MORNING - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS ARE LITERALLY COMING APART [DEVICE BREAKAGE]. SPENT A LONG TIME TRYING TO DIG THE PIECES/FIBERS OUT THIS MORNING - TAMPON [COMPLICATION OF DEVICE REMOVAL]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT TAMPONS ARE COMING APART. NO SERIOUS INJURY REPORTED.
TRYING TO DIG THE PIECES/FIBERS OUT THIS MORNING - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS ARE LITERALLY COMING APART [DEVICE BREAKAGE]. SPENT A LONG LONG TIME TRYING TO DIG THE PIECES/FIBERS OUT THIS MORNING - TAMPON .[COMPLICATION OF DEVICE REMOVAL]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT TAMPONS ARE COMING APART. NO SERIOUS INJURY REPORTED. FOLLOW-UP: 07-MAR-2022: RETURNED PRODUCT IDENTIFIED AS ONTEX L. PLEASE SEE REPORT 1216894-2022-00017 REGARDING THE PRODUCT THAT WAS NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2537893 | L.TAMPONSORGCOTTONCOMPAKSUPER | TAMPON, MENSTRUAL, UNSCENTED | HEB | ONTEX HYGIENEARTIKEL GMBH | 1825474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |