FDA Adverse Event
Injury
Summary report: N
SEVENTH GENERATION
MDR report key: 12304035
·
Received August 10, 2021
Report
- Report Number
- 1648563-2021-00006
- Event Type
- Injury
- Date Received
- August 10, 2021
- Date of Event
- July 11, 2021
- Report Date
- August 10, 2021
- Manufacturer
- FEMPRO CONSUMER PRODUCTS ULC
- Product Code
- HHD
- UDI-DI
- 00732913446827
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- VT, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
SONUMER USED OUT ULTRA THIN SUPER LONG PADS AND EXPERIENCES A RASH IN ALL AREAS OF CONTACT WITH OUR PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1201853 | SEVENTH GENERATION | ULTRA THIN PAD- SUPER LONG | HHD | FEMPRO CONSUMER PRODUCTS ULC | 67436079 | 33 019 02:32:32. | 00732913446827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |