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

Model Number ES29201022

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2019

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.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, the patient experienced "severe consolidation" on the right groin three weeks after surgery.The patient was unable to inflate or deflate the pump.One month later, intervention / device removal occurred, but there was "severe consolidation" around the reservoir and it could not be removed.It was unclear what consolidation referred to.The reported information stated it could not be referred to as a hematoma, but a "consolidation" probably resulting from the collection of blood around the reservoir.It could not be removed as it might lead to severe bleeding.

Manufacturer Narrative

A titan touch and two cylinders were received.Visual examination of the returned components revealed no abnormalities that would have contributed to the report of "consolidation".

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10889928
• MDR Text Key: 217949747
• Report Number: 2125050-2020-01135
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29201022
• Device Catalogue Number: ES2920
• Device Lot Number: 6625441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR