MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS 700 15CM , 100 ML RESERVOIR WITH 3 CM EXTENDERS; PROSTHESIS, PENIS, INFLATABLE

Model Number AMS 700

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Rupture (2208); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Patient presented to hospital emergency room with penile pain and what appeared to be a foreign body protruding from the meatus.Patient's history reveals he had a penile implant placed at another facility approximately [number redacted] years ago.Urology examination found the foreign body was one of the penile shaft segments that had eroded through the urethra wall causing urinary obstruction and leading to infection.Surgical removal was done where they found a rupture/breach of the parylene covering on the right side cylinder which was the side with erosion and protrusion into the urethrae occurred.At this time, the patient is still hospitalized and experiencing urinary retention.Review of patient's history shows he had a ipp placed originally in [date redacted]; it was replaced on [date redacted] at the (b)(6) hospital and clinics (exact device data is not available to this reporter) and a revision was done without replacement on [date redacted].

• Brand Name: AMS 700 15CM , 100 ML RESERVOIR WITH 3 CM EXTENDERS
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 14266076
• MDR Text Key: 290539585
• Report Number: 14266076
• Device Sequence Number: 1
• Product Code: JCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AMS 700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Device Age: 16 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White