FDA Adverse Event
Injury
Summary report: N
PLASTIBELL
MDR report key: 3015762
·
Received March 16, 2013
Report
- Report Number
- MW5029428
- Event Type
- Injury
- Date Received
- March 16, 2013
- Date of Event
- March 10, 1987
- Report Date
- March 16, 2013
- Manufacturer
- .
- Product Code
- FHG
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
WAS CIRCUMCISED USING A PLASTIBELL DEVICE; LOSS OF FORESKIN RESULTED IN ANORGASMIA, ERECTILE DYSFUNCTION, EXCESSIVE AND UNEVEN SCARRING, TEARING OF SKIN UPON ERECTION, AND SEVERE PSYCHOLOGICAL TRAUMA LATER IN LIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111167 | PLASTIBELL | PLASTIBELL | FHG | . |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Disability |