FDA Adverse Event
Injury
Summary report: N
DUREX EXTRA SENSITIVE LATEX
MDR report key: 2142479
·
Received June 22, 2011
Report
- Report Number
- MW5021123
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- May 28, 2011
- Report Date
- June 22, 2011
- Manufacturer
- DUREX NORCROSS
- Product Code
- HIS
- Report Source
- Voluntary report
- Reporter Location
- WY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METAL WASHER WAS LOCATED INSIDE FOIL WRAPPER OF CONDOM. REASON FOR USE: BIRTH CONTROL, STD/STI PREVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUREX EXTRA SENSITIVE LATEX | LATEX CONDOM | HIS | DUREX NORCROSS | EXTRA SENSITIVE | VT1006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Disability |