FDA Adverse Event
Injury
Summary report: N
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
MDR report key: 17627124
·
Received August 25, 2023
Report
- Report Number
- 1219109-2023-00293
- Event Type
- Injury
- Date Received
- August 25, 2023
- Date of Event
- January 1, 2023
- Report Date
- August 25, 2023
- 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
Narratives
Additional Manufacturer Narrative · 0
THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.
Description of Event or Problem · 0
TOXIC SHOCK SYNDROME [TOXIC SHOCK SYNDROME]. HAVE TO DIG OUT TAMPON - VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON STRING DISCONNECTS, STRING HAS BEEN ¿UNSPOOLING¿, THE STRING UNRAVELS, STRING HAD COME LOOSE - TAMPON [DEVICE BREAKAGE]. TAMPON STRING DISCONNECTS... HAVE TO DIG OUT TAMPON [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT THE TAMPON STRING HAS BEEN UNSPOOLING AND DISCONNECTED DURING REMOVAL. SERIOUS INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1815780 | TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Hospitalization| R |