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

Model Number	QN89161400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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, reservoir tubing leak (tear) the lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
Additional Manufacturer Narrative
D4 lot number: 3617241.A reservoir was received for analysis.A separation was noted in the reservoir inlet tubing adjacent to the reservoir inlet strain relief.Testing revealed this to be a site of leakage.Microscopic evaluation revealed the surfaces of the site of separation to be rough and irregular, indicating sufficient stress was exerted to separate the site.Based on examination of the returned product, it was concluded that the positioning, in combination with device usage over time, may have contributed sufficient stress(s) to cause a separation of the reservoir inlet tubing adjacent to the tubing/strain relief junction.A separation of this type could then allow the loss of fluid, rendering the device inoperable.

• Brand Name: TITAN
• Common Device Name: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11291954
• Report Number: 2125050-2021-00104
• Device Sequence Number: 18985147
• Product Code: FHW
• UDI-Device Identifier: 05708932323604
• UDI-Public: 05708932323604
• Combination Product (Y/N): N
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QN89161400
• Device Catalogue Number: QN8916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1