MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. SPECTRA 12MMX16CM; PROSTHESIS, PENILE

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

Prior to placement, coating on the metal implant ripped and metal was exposed.

• Brand Name: SPECTRA 12MMX16CM
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 10000374
• MDR Text Key: 189003265
• Report Number: 10000374
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA