FDA Adverse Event
Malfunction
Summary report: N
JUSTTAMPONSNATURALSSUPER
MDR report key: 10283706
·
Received July 16, 2020
Report
- Report Number
- 1219109-2020-00168
- Event Type
- Malfunction
- Date Received
- July 16, 2020
- Report Date
- June 19, 2020
- 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
Narratives
Additional Manufacturer Narrative · 1
THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
Description of Event or Problem · 1
HAD TO DIG OUT LITTLE BITS OF COTTON FROM MYSELF- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON FELL APART [DEVICE BREAKAGE]. PAINFUL- VAGINA [VULVOVAGINAL PAIN]. TAMPON FELL APART WHEN TAKING IT OUT. DIG OUT LITTLE BITS OF COTTON FROM MYSELF. PAINFUL [COMPLICATION OF DEVICE REMOVAL]. CONSUMER STATED ON SOCIAL MEDIA THAT THE TAMPON FELL APART WHEN SHE WAS TAKING IT OUT. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749347 | JUSTTAMPONSNATURALSSUPER | TAMPON, MENSTRUAL, UNSCENTED | HEB | TAMBRANDS MANUFACTURING, INC | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |