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

Model Number	ESR8182400
Medical Device Problem Codes	Material Fragmentation (1261); Material Frayed (1262)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
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.Should additional facts prompt us to alter or supplement any information of 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 the available information, unknown issue with inflation.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.A search was completed for other complaints, and there were no other complaints found for this lot number.One furlow was received for evaluation, the inserter was marked with a manufacturing date of nov 2017, after the set up of the new control.A prototype was supplied by the supplier.The prototype included a rounded chamfer.Visual examination observed clean edges without noticeable burrs.The device was reviewed following the instructions for use and found that it operate smoothly and did not result in damage to the suture." the component (b)(4) lot 170916150086 is made by our supplier and therefore is subject to incoming inspection control(to this date of the control) which didn't reveal any recorded anomaly in connection with the described incident.Checking the quality databases revealed that this issue is known.The furlow was tested again with the same control and was able to conform.A lot review was completed, which didn't reveal any recorded anomaly in connection with the described event.Based on the above, this complaint is not confirmed as a product defect.

• Brand Name: TITAN OTR INFRA ZERO ANG
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7165576
• Report Number: 2125050-2018-00007
• Device Sequence Number: 16610206
• Product Code: FHW
• UDI-Device Identifier: 05708932487542
• UDI-Public: 05708932487542
• 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 Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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
• Operator of Device: No Information
• Device Model Number: ESR8182400
• Device Catalogue Number: ESR8182400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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: Other
• Patient Age: 67 YR