MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700; PROSTHESIS, PENIS, INFLATABLE

Lot Number 72401850

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

Inflatable penile prosthesis (ipp) was removed.Operative report simply says "malfunction".Manufacturer is finalizing the return of both devices involved in this incident.

• Brand Name: AMS 700
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., w; minnetonka MN 55343
• MDR Report Key: 3702970
• MDR Text Key: 4270124
• Report Number: 3702970
• Device Sequence Number: 1
• Product Code: JCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2014

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: Invalid Data
• Device Lot Number: 72401850
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 93