TAMPAXTAMPONSRADIANTRADIANTREGNORUNSCNT7CT
Report
- Report Number
- 1219109-2023-00129
- Event Type
- Malfunction
- Date Received
- May 10, 2023
- Report Date
- July 6, 2023
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K110669
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE LOT CODE INVESTIGATION ON PQC(PRODUCT OR COMPONENT; RETAINED IN BODY), COMPLETED ON MAY 9,2023. AN INVESTIGATION IS IN PROGRESS FOR NEWLY ADD A PQC(PRODUCT IS COMING APART, IN PIECES, SHREDDING) ON MAY17,2023
PRODUCT INVESTIGATION IS IN PROGRESS.
TAMPON BROKEN INSIDE - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. BROKEN INSIDE- TAMPON [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON BROKE INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
TAMPON BROKEN INSIDE - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] BROKEN INSIDE- TAMPON [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON BROKE INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
TAMPON BROKEN INSIDE - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. BROKEN INSIDE- TAMPON [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA EMAIL THAT THE TAMPON BROKE INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227792 | TAMPAXTAMPONSRADIANTRADIANTREGNORUNSCNT7CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 2167208001 V3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |