MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES28222400

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.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.

Event Description

According to the available information, erosion was noted.Cross-over functioning implant.Another inflatable penile prosthesis was implanted.

Event Description

Clarify that it was reported that during explant, cross-over was noted, the implant was functioning.Erosion was also noted.

Manufacturer Narrative

This follow-up was created to clarify the original event description and conclusion of the investigation.A titan touch pump, reservoir, and two cylinders were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of erosion, or 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, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH INFR ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9604341
• MDR Text Key: 182570325
• Report Number: 2125050-2020-00065
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539142
• UDI-Public: 05708932539142
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28222400
• Device Catalogue Number: ES2822
• Device Lot Number: 5121324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No