FDA Adverse Event Injury Summary report: N

PENILE PROSTHESIS - PENILE IMPLANT

MDR report key: 2009060 · Received February 25, 2011

Report

Report Number
MW5019645
Event Type
Injury
Date Received
February 25, 2011
Date of Event
June 23, 2010
Report Date
September 14, 2007
Manufacturer
COLOPLAST CORP
Product Code
FAE
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A CONSULTATION WITH A UROLOGIST CONCERNING A PENILE IMPLANT IN (B)(6) 2010 AND (B)(6) 2010. DURING BOTH CONSULTATIONS, THE UROLOGIST WAS VERY POSITIVE ABOUT THE IMPLANT. I WENT WITH THE PENILE IMPLANT ON (B)(6) 2010. I HAD ONE NIGHT STAY IN THE HOSPITAL. THEN ABOUT THE (B)(6), I CONTRACTED A YEAST INFECTION IN THE GROIN AREA AND WAS IN MUCH PAIN. I WENT TO THE UROLOGIST ON (B)(6) 2010 AND RECEIVED TREATMENT FOR THE INFECTION. I CONTINUED IN PAIN FROM THE IMPLANT AFTER THE YEAST INFECTION WAS CURED. I WENT BACK TO THE UROLOGIST ON (B)(6) 2010 IN LOT OF PAIN. I UNDERWENT EMERGENCY SURGERY ON THE (B)(6), AS THE UROLOGIST THOUGHT PERHAPS A NERVE ENDING HAD CONTINUED TO GROW. I WAS IN THE HOSPITAL 2 NIGHTS WITH THIS SURGERY. I CONTINUED IN CONSIDERABLE PAIN FOR THE NEXT MONTH. DURING THIS TIME, AND BEGINNING WITH THE IMPLANT, I WAS TAKING 5-6 IBUPROFEN PER DAY ALONG WITH OXYCODONE, ALONG WITH KEEPING AN ICE PACK ON THE AFFECTED AREA DAILY TRYING TO CONTROL THE PAIN AND SWELLING. ON (B)(6) 2010, I AWOKE WITH A THICK FLUID COMING OUT OF MY SCROTUM WHERE THE SURGERY WAS PERFORMED. I WENT TO THE UROLOGIST. HE TOOK A CULTURE AND STARTED ME ON ANTIBIOTICS AND TOLD ME I HAD A (B)(6). I RETURNED 2 MORE TIMES AND BOTH TIMES I WENT TO THE UROLOGIST. IT SHOULD BE NOTED I AM NOT DIABETIC. FINALLY ON (B)(6) 2010, I WAS HOSPITALIZED AGAIN AND HE REMOVED THE PENILE IMPLANT. I WENT BACK TO THE UROLOGIST ON (B)(6) 2011 AND HE SAID I WAS WELL ENOUGH TO START THE VACUUM PUMP AGAIN. I FOUND OUT AFTER USING THE PUMP, I COULD NOT GET AN ERECTION AT ALL. I CONTACTED A MEDICAL SUPPLY PERSON FOR A NEW VACUUM PUMP AND WHILE VISITING WITH HIM, HE SAID HE HAD HEARD A LOT OF HORROR STORIES ABOUT PENILE IMPLANT. WHAT IS SO DISAPPOINTING IS AFTER GOING THROUGH ALL THE PAIN AND INFECTION, I HAVE LESS NOW THAN WHEN I STARTED IN (B)(6) 2010.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PENILE PROSTHESIS - PENILE IMPLANT FAE COLOPLAST CORP

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization| R| S