MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES89142400
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/21/2019
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 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 the available information, erosion/extrusion was reported.The prosthesis fully functioned and was not broken.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation and additional implant and event information.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of erosion/ extrusion.Quality accepts the physician's observations as to the reason for surgical intervention.
Event or Problem Description
Per additional information received, extruded (r) cylinder.

• Brand Name: TITAN SCROTAL ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• MDR Report Key: 8533877
• Report Number: 2125050-2019-00294
• Device Sequence Number: 16512482
• Product Code: FHW
• UDI-Device Identifier: 05708932487306
• UDI-Public: 05708932487306
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: Lay User/Patient
• Device Model Number: ES89142400
• Device Catalogue Number: ES8914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: 57 YR