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

Model Number EN29181022

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports 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, a pump tubing leak (tear) was noted.The patient had a revision surgery.

Manufacturer Narrative

This follow-up was created to document the additional event information.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device become available, or additional information is received, the complaint will be re-evaluated according to procedures.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.

Event Description

Additional information received indicated that a leak from the tear was observed on the reservoir tubing.

• Brand Name: TITAN TOUCH NB SCROT ZERO 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9571972
• MDR Text Key: 174475910
• Report Number: 2125050-2020-00030
• 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
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EN29181022
• Device Catalogue Number: EN2918
• Device Lot Number: 6240167
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR