FDA Adverse Event
Malfunction
Summary report: N
TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT36CT
MDR report key: 24545585
·
Received March 9, 2026
Report
- Report Number
- 1219109-2026-00054
- Event Type
- Malfunction
- Date Received
- March 9, 2026
- Report Date
- May 5, 2026
- 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
Additional Manufacturer Narrative · 0
PRODUCT INVESTIGATION IS IN PROGRESS.
Additional Manufacturer Narrative · 0
PRODUCT INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 0
PIECES OF THE TAMPON GOT STUCK INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] , PIECES OF THE TAMPON (GOT STUCK INSIDE OF ME)- TAMPON [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT PIECES OF THE TAMPON GOT STUCK INSIDE OF HER. NO SERIOUS INJURY REPORTED.
Description of Event or Problem · 0
PIECES OF THE TAMPON GOT STUCK INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] PIECES OF THE TAMPON (GOT STUCK INSIDE OF ME)- TAMPON [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT PIECES OF THE TAMPON GOT STUCK INSIDE OF HER. NO SERIOUS INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60875 | TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT36CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 5308243065W00163, 5340243070W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |