FDA Adverse Event
Injury
Summary report: N
U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB
MDR report key: 8659663
·
Received May 31, 2019
Report
- Report Number
- 3011109575-2019-01280
- Event Type
- Injury
- Date Received
- May 31, 2019
- Date of Event
- March 1, 2019
- Report Date
- May 31, 2019
- Manufacturer
- K-C AFC MANUFACTURING, S. DE R.L. DE C.V
- Product Code
- HEB
- UDI-DI
- 00036000998382
- PMA / PMN Number
- K112635
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.
Description of Event or Problem · 1
CONSUMER E-MAILED TO REPORT THAT THE TAMPON STRINGS BROKE AND SHE HAD TO HAVE THE TAMPONS SURGICALLY REMOVED BY A DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453698 | U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB | TAMPON, MENSTRUAL, UNSCENTED | HEB | K-C AFC MANUFACTURING, S. DE R.L. DE C.V | SUPER PLUS | 00036000998382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |