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

Model Number ES29221022

Device Problems Break (1069); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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 Description

According to the available information, kinking/split in left tubing near pump were reported.The device was explanted and replaced with another device.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion in the shorter exhaust tube of the pump.Testing revealed this to be a site of leakage.Partial separations within abrasion were noted in the shorter length pump exhaust tube and pump inlet tube.Testing revealed these to not be sites of leakage.Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, could most likely contribute to sufficient stress(s) to separate the exhaust tubing of the shorter length pump exhaust tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.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 TOUCH SCRO ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9599392
• MDR Text Key: 175444445
• Report Number: 2125050-2020-00052
• Device Sequence Number: 1
• Product Code: FHW
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29221022
• Device Catalogue Number: ES2922
• Device Lot Number: 5164896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR