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

Model Number EN29141022

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

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.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, erosion exposure to glans.

Manufacturer Narrative

This follow-up mdr is created to document the returned device updated codes.As examination of the device may not conclusively confirm or disprove the report of erosion.Quality accepts the physician's observations as to the reason for surgical intervention.

• Brand Name: TITAN TOUCH NB SCROT ZERO 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; 3050 ; DA 3050
• MDR Report Key: 8641934
• MDR Text Key: 146112657
• Report Number: 2125050-2019-00409
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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: 4460853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR