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