TAMPAXTAMPONSPEARLPOCKETPEARLCOMPAKMIXEDNONDO96CT
Report
- Report Number
- 1219109-2022-00373
- Event Type
- Malfunction
- Date Received
- September 6, 2022
- Report Date
- November 3, 2022
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K133244
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
PRODUCT WAS IDENTIFIED AS A NON P&G TAMPONS PRODUCT.
CORRECTION: PRODUCT NAME THERE IS INSUFFICIENT INFORMATION TO PERFORM A PRODUCT INVESTIGATION.
UTI [URINARY TRACT INFECTION] . TAMPON STUCK INSIDE- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. MISSING STRING - TAMPON [DEVICE PHYSICAL PROPERTY ISSUE]. CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT TAMPON WAS MISSING A STRING. NO SERIOUS INJURY REPORTED.
TAMPON STUCK INSIDE- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] UTI [URINARY TRACT INFECTION] MISSING STRING - TAMPON [DEVICE PHYSICAL PROPERTY ISSUE] CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT TAMPON WAS MISSING A STRING. NO SERIOUS INJURY REPORTED. FOLLOW-UP: (B)(6) 2022: RETURNED PRODUCT RECEIVED CONFIRMED THAT THE TAMPONS WERE NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA, AND THIS CASE WILL BE DELETED FROM OUR DATABASE.
TAMPON STUCK INSIDE- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT] UTI [URINARY TRACT INFECTION] MISSING STRING - TAMPON [DEVICE PHYSICAL PROPERTY ISSUE] CASE NARRATIVE: CONSUMER REPORTED VIA E-MAIL THAT TAMPON WAS MISSING A STRING. NO SERIOUS INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2500937 | TAMPAXTAMPONSPEARLPOCKETPEARLCOMPAKMIXEDNONDO96CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |