MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES28181022

Device Problems Inflation Problem (1310); Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 08/22/2018

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, prosthesis does not inflate/cylinder cable is missing.

Manufacturer Narrative

This follow-up mdr is created to document the additional information and updated device code.

Event Description

Additional information stated auto inflation.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and updated device information.A titan touch, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation in the reservoir bladder.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be smooth and non-striated, indicating contact with sharp instrumentation.No functional abnormalities were noted with the pump or two cylinders.Because the available information did not provide any indication as to what factors may have contributed to the device not inflating and because no functional abnormalities were observed, quality cannot determine the cause of the reported event.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.Because these components were released according to manufacturing and quality control procedures, qa concluded that the observed instrument separation in the reservoir bladder occurred subsequent to the device packaging being opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, quality concluded that the separation most likely occurred during or subsequent to explant.This separation is not associated with the cause for failure.

• Brand Name: TITAN TOUCH INFR ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• MDR Report Key: 8330519
• MDR Text Key: 135858756
• Report Number: 2125050-2019-00084
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES28181022
• Device Catalogue Number: ES2818
• Device Lot Number: 6110857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR