TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREGNORUNSCNT16CT
Report
- Report Number
- 1219109-2023-00084
- Event Type
- Malfunction
- Date Received
- April 3, 2023
- Report Date
- July 11, 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
PRODUCT INVESTIGATION IS IN PROGRESS.
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE LOT CODE INVESTIGATION ON PQC(PRODUCT OR COMPONENT; RETAINED IN BODY), COMPLETED ON APR.7,2023. AN INVESTIGATION IS IN PROGRESS FOR NEWLY ADD A PQC(PRODUCT IS COMING APART, IN PIECES, SHREDDING) ON JUN. 9, 2023.
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
TAMPON STUCK INSIDE [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON BROKE [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT HALF THE TAMPON BROKE AND BECAME STUCK IN BODY. NO SERIOUS INJURY WAS REPORTED.
TAMPON STUCK INSIDE [FOREIGN BODY IN REPRODUCTIVE TRACT] TAMPON BROKE [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT HALF THE TAMPON BROKE AND BECAME STUCK IN BODY. NO SERIOUS INJURY WAS REPORTED.
TAMPON STUCK INSIDE [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON BROKE [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT HALF THE TAMPON BROKE AND BECAME STUCK IN BODY. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580415 | TAMPAXTAMPONSRADIANTRADIANTFULLSIZEREGNORUNSCNT16CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 2141208000 V3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |