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

Model Number ES28202400

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

Patient Problem No Information (3190)

Event Date 06/12/2019

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, the patient had a hard pump.Below are the steps the patient's physician took to troubleshoot the issue: met with the patient at his office and followed the hard pump techniques from a consulting physician's video, a coloplast engineering video, the "hard pump video", pressed the deflate button and pump and tried to use a qtip to move the disk.The patient's physician sent the patient home and recommended hot baths to try to manipulate the pump.An office visit was set up for the next week.Phone call was set up with the consulting physician to troubleshoot.The consulting physician followed up again with the patient's physician the day before the patient's next office visit.The patient's physician met with the coloplast sales representative to review options.The patient's physician met with the patient.He was still not able to release the hard pump.Once the patient was under anesthesia, the physician tried various methods to release the pump without success.The titan touch pump was exchanged for a different titan pump.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump was received.The inlet tube with connector was detached for testing purposes.Examination and testing of the returned pump revealed no functional abnormalities 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 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8966989
• MDR Text Key: 156890005
• Report Number: 2125050-2019-00720
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539135
• UDI-Public: 05708932539135
• 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: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28202400
• Device Catalogue Number: ES2820
• Device Lot Number: 6157491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR