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

Model Number	E179282400
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to available information, this device was explanted and replaced due to failure to inflate post implant.No other adverse patient effects were reported.
Additional Manufacturer Narrative
A titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.No functional abnormalities were noted with the pump.A separation was noted in the exhaust tube of cylinder 1.This was a site of leakage.Microscopic examination of the separation revealed a central groove, indicating contact with sharp instrumentation such as a needle.No functional abnormalities were noted with cylinder 2.A separation was noted in the reservoir bladder.This was a site of leakage.Microscopic examination of the separation revealed a suture like material inserted into the bladder.The information indicated the device was implanted for approximately 10 weeks.Suture type material was noted through the reservoir bladder, which resulted in leakage at the puncture site, along with a separation in the exhaust tube of cylinder 1.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separations in the reservoir bladder and exhaust tube of cylinder 1 occurred subsequent to the device packaging being opened.However, the information received does not provide further details as to when the suture like material may have been introduced into the reservoir bladder or separation in the cylinder 1 exhaust tube.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
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11870834
• Report Number: 2125050-2021-00609
• Device Sequence Number: 923703
• Product Code: FHW
• UDI-Device Identifier: 05708932487467
• UDI-Public: 05708932487467
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/17/2025
• Device Model Number: E179282400
• Device Catalogue Number: E17928
• Device Lot Number: 7356196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention