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

Model Number ES29201022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a revision is scheduled to shorten the tubing.Revision has not yet occurred.Information received 09/03/2020: revision scheduled for (b)(6) 2020: all components functioning.No implant fault.All components remain in situ except connectors.Additional information received 09/06/2020: the revision surgery occurred on (b)(6)2020.The clinical consequences are that the patient was operated on again and has to go through another period of healing.

• Brand Name: TITAN
• 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: 10611114
• MDR Text Key: 209335453
• Report Number: 2125050-2020-00908
• 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 Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Device Operator: No Information
• Device Model Number: ES29201022
• Device Lot Number: 7051025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1