FDA Adverse Event
Injury
Summary report: N
REALITY CONDOMS
MDR report key: 12058706
·
Received June 23, 2021
Report
- Report Number
- MW5102111
- Event Type
- Injury
- Date Received
- June 23, 2021
- Date of Event
- July 15, 2009
- Report Date
- June 15, 2021
- Manufacturer
- THE FEMALE HEALTH CO.
- Product Code
- MBU
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD TO GO PERIODIC VAGINAL SCREENINGS HAD 2 PREVIOUSLY TUBAL LIGATIONS. IMPLANTED ON (B)(6) 1993, EXPLANTED ON (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951351 | REALITY CONDOMS | SINGLE-USE INTERNAL CONDOM | MBU | THE FEMALE HEALTH CO. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |