FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
MDR report key: 17834866
·
Received September 28, 2023
Report
- Report Number
- 3011109575-2023-00213
- Event Type
- Malfunction
- Date Received
- September 28, 2023
- Date of Event
- August 29, 2023
- Report Date
- September 28, 2023
- Manufacturer
- K-C AFC MANUFACTURING, S. DE R.L. DE C.V
- Product Code
- HEB
- UDI-DI
- 00036000515879
- PMA / PMN Number
- K172118
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RECORDS DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED AND THE FINISHED PRODUCT MET ALL QUALITY RELEASE CRITERIA AND SPECIFICATIONS WERE WITHIN ALLOWABLE LIMITS PRIOR TO RELEASE. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURE.
Description of Event or Problem · 0
REPORT 3 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. SHE WAS ABLE TO USE THE REMAINING PIECE OF STRING TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099154 | U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB | TAMPON, MENSTRUAL, UNSCENTED | HEB | K-C AFC MANUFACTURING, S. DE R.L. DE C.V | SUPER | NN306213D0050 | 00036000515879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female |