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

Model Number	5177701400
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Event or Problem Description
According to the available information, though not verified, tubing broke close to pump.Device being returned.Device removed and replaced.
Additional Manufacturer Narrative
According to the available information, the inflatable penile prosthesis was removed and replaced on (b)(6) 2021 as the tubing broke close to the pump.Based on examination of the returned product, it was concluded that the abrasion marks noted on the longer pump exhaust tubing and pump inlet tubing indicated they may have overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, may have contributed sufficient stress(s) to cause a separation in the shorter pump exhaust tubing strain relief adjacent to the pump body.A separation of this type may then allow the loss of fluid, rendering the device inoperable.A review of the device history record confirmed that the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11336718
• Report Number: 2125050-2021-00147
• Device Sequence Number: 14049532
• Product Code: FHW
• UDI-Device Identifier: 05708932487467
• UDI-Public: 05708932487467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: 5177701400
• Device Catalogue Number: 517770
• Device Lot Number: 5352012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: Required Intervention
• Patient Age: 65 YR