MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES28202400
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/31/2019
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, only the rear tip extenders were replaced with a different size.The device appeared to inflate/deflate without difficulty; however the right side cylinder had crossover (distal).
Additional Manufacturer Narrative
This follow-up mdr is created to document the corrected device information and implant date, and the conclusion of the investigation.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of crossover quality accepts the physician's observations as to the reason for surgical intervention.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

• Brand Name: TITAN TOUCH INFR ZERO ANG 20CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9045414
• Report Number: 2125050-2019-00751
• Device Sequence Number: 2882569
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: ES28202400
• Device Catalogue Number: ES2820
• Device Lot Number: 5585212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: 49 YR