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

Model Number 720185-01

Device Problem Microbial Contamination of Device (2303)

Patient Problems Failure to Anastomose (1028); Cellulitis (1768); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 12/11/2019

Event Type  malfunction  

Event Description

Patient underwent implanted penile prosthesis placement.He experienced cellulitis within 15 days and was hospitalized for iv antibiotic therapy.The next month, the ipp was explanted and a new device placed.A pinpoint hole was found along his original incision during this procedure.No purulent drainage was found, so the wound was thoroughly washed out and a new ipp placed.One month later, the patient had to return to surgery for continued infective state and the ipp was removed.Again, no purulent drainage was found but the pinpoint hole in the incision line was still present.The ipp was removed and wash out was done again.A 3rd ipp was placed.He was sent home on antibiotics after each intervention.Patient has not returned to facility since this time.Tissue glue was used all three times to close the skin.

• Brand Name: CONCEAL
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 9726846
• MDR Text Key: 179945759
• Report Number: 9726846
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• 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