FDA Adverse Event
Malfunction
Summary report: N
TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT18CT
MDR report key: 24979155
·
Received April 24, 2026
Report
- Report Number
- 1219109-2026-00105
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Report Date
- May 13, 2026
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- UDI-DI
- 00073010009868
- 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
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
Additional Manufacturer Narrative · 0
PRODUCT INVESTIGATION IS IN PROGRESS.
Description of Event or Problem · 0
TAMPONS BROKE OPEN INSIDE OF ME...HAD TO TRY AND GET THE MATERIAL FROM INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BROKE OPEN [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT THE TAMPON BROKE OPEN WHILE INSIDE OF HER. NO SERIOUS INJURY REPORTED.
Description of Event or Problem · 0
TAMPONS BROKE OPEN INSIDE OF ME. HAD TO TRY AND GET THE MATERIAL FROM INSIDE OF ME- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPONS BROKE OPEN [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT THE TAMPON BROKE OPEN WHILE INSIDE OF HER. NO SERIOUS INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 548275 | TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT18CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 5354243011 43 07:17 | 00073010009868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |