FDA Adverse Event
Malfunction
Summary report: N
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
MDR report key: 9292373
·
Received November 7, 2019
Report
- Report Number
- 3011109575-2019-01533
- Event Type
- Malfunction
- Date Received
- November 7, 2019
- Date of Event
- October 16, 2019
- Report Date
- November 7, 2019
- Manufacturer
- K-C AFC MANUFACTURING, S. DE R.L. DE C.V
- Product Code
- HEB
- UDI-DI
- 00036000998399
- PMA / PMN Number
- K172118
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION.
Description of Event or Problem · 1
CONSUMER REPORTED THE STRING WAS MISSING FROM A TAMPON LEAVING THE TAMPON STUCK INSIDE HER. SHE WAS ABLE TO MANUALLY REMOVE THE TAMPON BUT THIS CAUSED EXCRUCIATING PAIN AND CRAMPING IN UTERUS. AFTER REMOVAL OF THE TAMPON, SHE EXPERIENCED PROLONGED MENSTRUATION WHICH SHE SPOKE TO HER GYNECOLOGIST ABOUT. HER PAIN HAS IMPROVED BUT THE BLEEDING HAS NOT RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085522 | U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB | TAMPON, MENSTRUAL, UNSCENTED | HEB | K-C AFC MANUFACTURING, S. DE R.L. DE C.V | REGULAR | NN906213D2326 | 00036000998399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |