L.TAMPONSORGCOTTONCOMPAKREG+SUPERNONDO45CT
Report
- Report Number
- 1219109-2022-00033
- Event Type
- Malfunction
- Date Received
- January 27, 2022
- Report Date
- December 30, 2021
- Manufacturer
- ONTEX HYGIENEARTIKEL GMBH
- Product Code
- HEB
- PMA / PMN Number
- K162746
- 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.
A PRODUCT INVESTIGATION IS IN PROGRESS.
COTTON IS SEPARATING FROM TAMPON DURING REMOVAL- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON IS SEPARATING FROM TAMPON [DEVICE BREAKAGE]. COTTON IS SEPARATING FROM TAMPON DURING REMOVAL, RETAINED [COMPLICATION OF DEVICE REMOVAL] CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON IS SEPARATING FROM THE TAMPON DURING REMOVAL. NO SERIOUS INJURY REPORTED.
COTTON IS SEPARATING FROM TAMPON DURING REMOVAL- VAGINA [FOREIGN BODY IN REPRODUCTIVE TRACT]. COTTON IS SEPARATING FROM TAMPON [DEVICE BREAKAGE]. COTTON IS SEPARATING FROM TAMPON DURING REMOVAL, RETAINED [COMPLICATION OF DEVICE REMOVAL]. CASE DESCRIPTION: CONSUMER REPORTED VIA E-MAIL THAT COTTON IS SEPARATING FROM THE TAMPON DURING REMOVAL. NO SERIOUS INJURY REPORTED. FOLLOW-UP: 07-FEB-2021: RETURNED PRODUCT IDENTIFIED AS ONTEX L. PLEASE SEE REPORT 1216894-2022-00007 FOR THE REPORT REGARDING THE ONTEX L. PRODUCT THAT WAS NOT MANUFACTURED BY TAMBRANDS MANUFACTURING, INC. IN AUBURN, MAINE, USA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102072 | L.TAMPONSORGCOTTONCOMPAKREG+SUPERNONDO45CT | TAMPON, MENSTRUAL, UNSCENTED | HEB | ONTEX HYGIENEARTIKEL GMBH | 0246D541121189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |