SPECTRA 720054-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-02-25 for SPECTRA 720054-01 manufactured by American Medical Systems, Inc..

Event Text Entries

[1714914] On (b)(6) 2010, the pt had an ams spectra concealable penile prosthesis implanted. On (b)(6)2010, this device was removed due to glans necrosis, it was stated that the "glans debrided, device removed. " the device was disposed of after the operation by the customer's pathology dept.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183959-2011-00083
• MDR Report Key: 2004139
• Report Source: 05
• Date Received: 2011-02-25
• Date of Report: 2011-02-22
• Date of Event: 2010-11-18
• Date Mfgr Received: 2011-02-22
• Device Manufacturer Date: 2010-02-01
• Date Added to Maude: 2011-03-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JON CORNELL, SR. MGR
• Manufacturer Street: 10700 BREN RD., WEST
• Manufacturer City: MINNETONKA MN 55343
• Manufacturer Country: US
• Manufacturer Postal: 55343
• Manufacturer Phone: 9529306670
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPECTRA
• Generic Name: CONCEALABLE PENILE PROSTHESIS
• Product Code: JCW
• Date Received: 2011-02-25
• Catalog Number: 720054-01
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 10700 BREN RD, WEST MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2011-02-25