FDA Adverse Event
Injury
Summary report: N
CROWN CONDOM
MDR report key: 2348533
·
Received October 25, 2011
Report
- Report Number
- 9610410-2011-00001
- Event Type
- Injury
- Date Received
- October 25, 2011
- Date of Event
- January 1, 2010
- Report Date
- June 1, 2010
- Manufacturer
- OKAMOTO RUBBER PRODUCTS CO., LTD.
- Product Code
- HIS
- PMA / PMN Number
- K893039/C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RETAIN SAMPLE FROM SAME LOT WAS EVALUATED BY THE METHOD OF ASTM D 3492 AND THE RESULT SATISFIED THE REQUIREMENT IN THAT STANDARD.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT HE HAD A CONDOM BROKEN ON FIRST USE AND HAD TO GO TO THE DOCTOR FOR POST EXPOSURE PROPHYLAXIS FOR (B)(6). HE ALSO MENTIONED THAT THIS IS GOOD CONDOM FOR VAGINAL SEX BUT MAYBE NOT FOR ANAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CROWN CONDOM | CONDOM | HIS | OKAMOTO RUBBER PRODUCTS CO., LTD. | 21000 | T410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |