MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROTHESIS

Model Number 5177501022

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, revision surgery.Proximal perforation of the corpora, leading to an oversizing of the implant and subsequent break down of corporal tissue.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11033752
• MDR Text Key: 222284783
• Report Number: 2125050-2020-01321
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: 5177501022
• Device Catalogue Number: 517750
• Device Lot Number: 6401900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2018
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR