L.TAMPONSORGCOTTONPLASTICSUPERNONDO
Report
- Report Number
- 1219109-2022-00250
- Event Type
- Malfunction
- Date Received
- July 1, 2022
- Report Date
- September 20, 2022
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K081555
- 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.
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
AN INVESTIGATION IS IN PROGRESS FOR RETURNED PRODUCT RECEIVED ON JULY 20, 2022.
TAMPONS BREAK OFF INSIDE OF ME AND I HAD TO FISH THEM OUT- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT TWO TAMPONS BROKE OFF INSIDE OF HER AND SHE HAD TO FISH THEM OUT. NO SERIOUS INJURY WAS REPORTED.
TAMPONS BREAK OFF INSIDE OF ME AND I HAD TO FISH THEM OUT- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT TWO TAMPONS BROKE OFF INSIDE OF HER AND SHE HAD TO FISH THEM OUT. NO SERIOUS INJURY WAS REPORTED.
TAMPONS BREAK OFF INSIDE OF ME AND I HAD TO FISH THEM OUT- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT TWO TAMPONS BROKE OFF INSIDE OF HER AND SHE HAD TO FISH THEM OUT. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1472699 | L.TAMPONSORGCOTTONPLASTICSUPERNONDO | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 2121243068W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |