FDA Adverse Event
Injury
Summary report: N
BEYOND SEVEN
MDR report key: 4707526
·
Received April 8, 2015
Report
- Report Number
- 9610410-2015-00001
- Event Type
- Injury
- Date Received
- April 8, 2015
- Manufacturer
- OKAMOTO RUBBER PRODUCTS CO., LTD.
- Product Code
- HIS
- PMA / PMN Number
- K893039
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INDIVIDUAL MENTIONED HE HAS NO PRODUCT LEFT ON HAND AND HE DOES NOT HAVE LOT IDENTIFICATION INFORMATION EITHER.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232599 | BEYOND SEVEN | CONDOM (RUBBER) CONTRACEPTIVE | HIS | OKAMOTO RUBBER PRODUCTS CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |