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

Model Number ES28222400

Device Problems Mechanical Jam (2983); Pumping Problem (3016)

Patient Problem No Information (3190)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

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, hard pump.

Event Description

Additional information indicated the issue was observed shortly after implantation.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device and the additional event information.A titan touch pump was received.Examination and testing of the returned pump noted abrasion on all tubes.No functional abnormalities were noted with the pump.The information received indicated a hard pump, but because no functional abnormalities were noted with the returned components, quality cannot confirm the complaint as reported.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, nonconformance's 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: 8909756
• MDR Text Key: 154841615
• Report Number: 2125050-2019-00672
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• 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: 4903925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR