MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 16CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89162400

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem No Information (3190)

Event Date 05/03/2019

Event Type  Injury  

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.

Event Description

According to the available information, no malfunction was noted.During repositioning of the device, the physician felt it necessary to replace the entire prosthesis.

Manufacturer Narrative

This follow-up mdr is created to document the corrected code and the conclusion of the investigation.Information received from the pathology department indicated that the device will not be returned per their protocol.Without the benefit of analyzing the product, quality cannot confirm any observations and cannot comment on the condition of the device.As quality's examination of the returned components may not conclusively confirm or disprove the report of repositioning, quality accepts the physician's observations of such as the reason for surgical intervention.If the device becomes available, or additional information is received, quality will re-evaluate this complaint.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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN SCROTAL ZERO ANG 16CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8660649
• MDR Text Key: 146784236
• Report Number: 2125050-2019-00437
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487320
• UDI-Public: 05708932487320
• 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: 07/18/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: ES89162400
• Device Catalogue Number: ES8916
• Device Lot Number: 3601223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR