MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC BIOFLEX TITAN; PROSTHESIS, PENILE

Model Number 16CM

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/22/2016

Event Type  malfunction  

Event Description

Patient with multiple medical comorbidities and erectile dysfunction, status post inflatable penile prosthesis placement about eight years ago.The device has recently malfunctioned and the patient presents today for full salvage and replacement.Recent office visit: patient with a history of prostate cancer, obesity, dm, htn, sleep apnea, gerd, history of celiac artery aneurysm who presents for evaluation of malfunctioning inflatable penile prosthesis (ipp).He had a coloplast about eight years ago.It was working well but about two months ago when he pumped it, it just burst.

• Brand Name: BIOFLEX TITAN
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road; minneapolis MN 55411
• MDR Report Key: 6144667
• MDR Text Key: 61442677
• Report Number: 6144667
• Device Sequence Number: 1
• Product Code: FAE
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 16CM
• Device Catalogue Number: 909916SNC
• Device Lot Number: 5615371008
• Other Device ID Number: SET, CYLINDER W/PUMP NARROW S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 37