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

Catalog Number 72401850

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Weakness (2145)

Event Date 10/11/2012

Event Type  malfunction  

Event Description

Operative report indicates "corporal weakness at the left base of ipp" manufacturer response for accessory penile ams 700, ams 700 (per site reporter): mfg's rep picked up device for inspection.

• Brand Name: AMS 700
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, LLC; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 6046239
• MDR Text Key: 58066409
• Report Number: 6046239
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 72401850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 91