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

Device Problem Pumping Problem (3016)

Patient Problem Scar Tissue (2060)

Event Date 07/22/2020

Event Type  malfunction  

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, the pump was not working.The pump was removed/replaced.The physician responded that it might be a sticky pump.When the physician took it out everything was intact and did work.The physician mentioned that the pump space had scar tissue so it might have caused it to stop working.The physician wasn't sure so he replaced it anyway.Otr pump.

Manufacturer Narrative

A titan one touch release pump was received for evaluation.Examination and testing of the returned components revealed the presence of surface abrasion on all pump tubing and on the detached inlet tubing.No functional abnormalities were noted with any of the returned components.The information received indicated the pump was not working, and that the physician believed that it may have been a ¿sticky pump¿, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN OTR
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10436515
• MDR Text Key: 203836631
• Report Number: 2125050-2020-00746
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR