FDA Adverse Event Malfunction Summary report: N

AMS LGX700 KIT

MDR report key: 5684566 · Received May 27, 2016

Report

Report Number
5684566
Event Type
Malfunction
Date Received
May 27, 2016
Date of Event
May 9, 2016
Report Date
May 20, 2016
Manufacturer
AMERICAN MEDICAL SYSTEMS INC
Product Code
FAE
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT WHO HAD AN INFLATABLE PENILE PROSTHESIS PLACED THIS YEAR HAD REMOVAL OF THE DEVICE AND COMPONENTS THREE MONTHS LATER BECAUSE OF INFECTED IPP (IMPLANTABLE PENILE PROSTHESIS). ONE MONTH POST-OP, PATIENT PRESENTED WITH SCROTAL CELLULITIS AND RECEIVED 2 WEEKS OF AUGMENTIN. PATIENT SEEN IN SURGEON'S OFFICE FOR SCROTAL INCISION FLUCTUANCE. PATIENT RETURNED 2 DAYS LATER WITH OPEN INCISION AND DRAINED PURULENT FLUID, SCROTAL REDNESS, FIRMNESS, SCROTUM AND SUPRAPUBIC AREA PAIN WITH SYMPTOMATIC FEVER AND CHILLS. WBC COUNT 12,000. PATIENT WAS HOSPITALIZED AND RECEIVED BROAD-SPECTRUM IV ANTIBIOTICS FOR 72 HOURS. WHITE COUNT NORMALIZED AND CELLULITIS RESOLVED. PATIENT TAKEN TO SURGERY FOR SALVAGE, WASHOUT WITH REMOVAL OF PROSTHESIS AND WASHOUT AND PLACEMENT OF AN AMS MALLEABLE PROSTHESIS. PATIENT DID WELL POST-OP AND DISCHARGED TO HOME IN STABLE CONDITION. THE FOLLOWING AMS IMPLANTS WERE EXPLANTED: KIT PNL PROS 700 ACC-LOG586582, MANUFACTURER AMERICAN MEDICAL SYSTEMS, LOT # 120468004. PROS PNL CONCEAL RESVR INHBZ LOG586582, MANUFACTURER AMERICAN MEDICAL SYSTEMS, LOT # 114621013. PROS PNL 700 ACC REAR 4 CM - LOG586582, MANUFACTURER AMERICAN MEDICAL SYSTEMS, LOT # 105010022. PROS PNL PENSCR 15 MM -LOG586582, MANUFACTURER AMERICAN MEDICAL SYSTEMS, LOT # 108341002. EXPLANTS ARE BEING SHIPPED TO AMERICAN MEDICAL SYSTEMS FOR FURTHER INVESTIGATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
339818 AMS LGX700 KIT INFLATABLE PENILE PROSTHESIS, KIT FAE AMERICAN MEDICAL SYSTEMS INC 700 ACC 120468004

Patients

Seq Age Sex Outcome Treatment
1 65 YR Other