MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH NB SCROT ZERO 14CM; INFLATABLE PENILE PROSTHESIS

Model Number EN29141022

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 5817114.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

Event Description

According to the available information, malfunction tubing fracture.Additional information received indicated a tear in the pump exhaust tubing.

Manufacturer Narrative

This follow up mdr is created to document the evaluation of the returned device.A touch pump, two cylinders and reservoir were received for evaluation.Examination and testing of the returned components revealed abrasion on the cylinder 2 exhaust tubing.Groups of striations, indicating contact with unshod instrumentation, were noted on the reservoir inlet tube and strain relief.Testing revealed these to not be sites of leakage.One of the pump exhaust tubes were detached to allow for testing.No functional abnormalities are noted with the pump, either cylinder or detached tubing.Because no functional abnormalities were noted with the returned components, other than instrument damage, the complaint cannot be confirmed as reported.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separations on the reservoir inlet tube and strain relief 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, it was concluded that the separations most likely occurred during or subsequent to explant.These separations are not associated with the cause for failure.

• Brand Name: TITAN TOUCH NB SCROT ZERO 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7939072
• MDR Text Key: 122851732
• Report Number: 2125050-2018-00721
• 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
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EN29141022
• Device Catalogue Number: EN2914
• Device Lot Number: 5817114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR