FDA Adverse Event
Malfunction
Summary report: N
TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT50CT
MDR report key: 18684815
·
Received February 12, 2024
Report
- Report Number
- 1219109-2024-00037
- Event Type
- Malfunction
- Date Received
- February 12, 2024
- Report Date
- February 19, 2024
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K081555
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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
CORD EITHER DETACHES BEFORE USE OR WHEN I GO TO REMOVE FROM BODY FALLS OFF [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT THE TAMPON CORD DETACHES BEFORE USE OR DURING REMOVAL. NO INJURY WAS REPORTED.
Description of Event or Problem · 0
CORD EITHER DETACHES BEFORE USE OR WHEN I GO TO REMOVE FROM BODY FALLS OFF [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT THE TAMPON CORD DETACHES BEFORE USE OR DURING REMOVAL. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087715 | TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT50CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 329324301469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female |