TAMPAXTAMPONSRADIANTRADIANTREGNORUNSCNT28CT
Report
- Report Number
- 1219109-2022-00303
- Event Type
- Malfunction
- Date Received
- July 27, 2022
- Report Date
- October 10, 2022
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K110669
- 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 (B)(6) 2022.
TAMPONS BREAK OFF INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT 3 TAMPONS BROKE INSIDE OF HER AND SHE SPENT AN EXCESS AMOUNT OF TIME REMOVING. NO SERIOUS INJURY WAS REPORTED.
TAMPONS BREAK OFF INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT 3 TAMPONS BROKE INSIDE OF HER AND SHE SPENT AN EXCESS AMOUNT OF TIME REMOVING. NO SERIOUS INJURY WAS REPORTED.
TAMPONS BREAK OFF INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BREAK OFF INSIDE OF ME [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT 3 TAMPONS BROKE INSIDE OF HER AND SHE SPENT AN EXCESS AMOUNT OF TIME REMOVING. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1356042 | TAMPAXTAMPONSRADIANTRADIANTREGNORUNSCNT28CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 2072243046W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |