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

Model Number 720185-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Incontinence (1928); Urinary Tract Infection (2120); Discharge (2225)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

Patient with history of total prostatectomy developed urinary incontinence and erectile dysfunction.On [date redacted], he had an implanted penile prosthesis (ipp) implanted.Within 15 days of discharge he had developed bleeding at the site, redness, pain and fever.He was readmitted and found to have a uti and scrotal wound drainage.He was started on iv antibiotics and then oral agents when discharged two days later.One month later, he was readmitted to have the ipp pump removed.A small hole was found in the skin lying over the ipp pump.A small fistula was also found and excised.The ipp pump was explanted and replaced with another.Patient discharged the same day.It is unclear if the ipp pump contributed to this event or if any defect was identified.It is available for examination by the company.

• Brand Name: AMS 700 SPHERICAL RESERVOIR
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 9382745
• MDR Text Key: 168232164
• Report Number: 9382745
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 720185-01
• Device Lot Number: 1000320682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Weight: 78