MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 720056-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 09/15/2014

Event Type  Injury  

Event Description

It was reported that the patient was scheduled to have his spectra concealable penile prosthesis removed due to recurring utis.At the removal surgery, the patient presented with infection and cylinder erosion near the glans.No further patient complications were reported in relation with this event.The patient outcome was described as "fine, implant was removed and closed up".

Manufacturer Narrative

The explanted device was returned and the analysis results indicate the device performed within specifications.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4130343
• MDR Text Key: 4921495
• Report Number: 2183959-2014-00438
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2018
• Device Catalogue Number: 720056-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR