MAUDE Adverse Event Report: COLOPLAST A/S TITAN; INFLATABLE PENILE PROSTHESIS

Model Number ES89222400

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Capsular Contracture (1761); Hematoma (1884)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, patient complaining of auto inflation of the device.The pump was removed/replaced.Additional information received stated the patient was not able to locate and manipulate his pump.He had a hematoma after initial implant and a large capsule formation around the pump.

Event Description

Additional information received, during the revision surgery the physician opened the scrotum and removed portions of the capsule.The original pump worked fine and there were no signs of auto inflation with the reservoir.Reservoir was drained and refilled to break the capsule that had formed around it as well (since the cylinders had been inflated for weeks and reservoir had been empty).The physician decided to cut in a new titan pump so he could reposition it lower in the scrotum.

Manufacturer Narrative

A titan pump and a portion of the detached inlet tubing with connector were received for evaluation.Microscopic examination revealed the presence of surface abrasion on the longer length pump exhaust tubing and on the detached inlet tubing.No functional abnormalities were found with any of the returned components.The information received indicated that the patient experienced auto inflation.The physician stated that during the revision surgery the capsule was broken that had formed around the reservoir and there were no signs of auto inflation.Examination of the returned components confirmed no functional abnormalities with the returned components, therefore, the complaint could not be confirmed as reported.The physician also reported that the patient experienced a hematoma and capsule formation.As examination of the device may not conclusively confirm or disprove these reports, quality accepts the physician's observations as to the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release and no anomalies were noted during production.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10098851
• MDR Text Key: 193438187
• Report Number: 2125050-2020-00402
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487382
• UDI-Public: 05708932487382
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89222400
• Device Catalogue Number: ES8922
• Device Lot Number: 6625394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 05/06/2020; 05/06/2020
• Supplement Dates FDA Received: 06/26/2020; 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR