MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS CONCEAL LOW PROFILE RESERVOIR WITH INHIBIZONE; PROSTHESIS, PENIS, INFLATABLE

Model Number 72018501

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  malfunction  

Event Description

Patient was admitted for removal of a malfunctioning inflatable penile prosthesis and replacement with an ams malleable penile prosthesis.The patient had satisfactory recovery and was discharged home without complications.Patient history: the patient had surgery (b)(6) 2015 for removal of nonfunctional malleable penile prosthesis and insertion of a 3-piece inflatable penile prosthesis at this hospital.The patient also had a penile implant revision (b)(6) 2017 at this hospital for a very minor leak at the connection.Additional implant information from 2015: implanted- ipp 24 cm + 5 rte.Access kit info: 700 acc model #72401850, log 368482, lot # 918491017, exp date: 1/9/2020.Manufacturer: ams sales corporation.Reservoir conceal flat: 100 ml, log 368482 m model # 72018501m lot # 920087015, exp.Date: 2017.Ams ms pump: model # 72404239, lot # 843486003.Ext rear tip cone: 12 x 14 mm x 5 cm, log 368482, model # 72404325, lot # 885472018.Manufacturer response for implantable penile prosthesis, ams ipp 700 acc (per site reporter).Ams will evaluate the device for cause of malfunction.

• Brand Name: AMS CONCEAL LOW PROFILE RESERVOIR WITH INHIBIZONE
• Type of Device: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 7706012
• MDR Text Key: 114576422
• Report Number: 7706012
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

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: No Information
• Device Model Number: 72018501
• Device Catalogue Number: LOG368482
• Device Lot Number: 920087015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 78