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

Model Number QSR9181400

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

This patient presented not able to inflate this device properly due to a reservoir leak.A device changeout was performed, upon which, it was discovered that there was a tear in the tubing closest to the pump.The original reservoir was abandoned and the device was replaced without any other patient adverse effects.

Manufacturer Narrative

A titan otr pump, two cylinders, and detached inlet tubing were received for analysis.A separation was noted through the longer pump exhaust tube.This was a site of leakage.The surfaces of this separation appear to be rough and irregular, indicating stress was exerted.A partial separation was noted on the shorter exhaust tube of the pump.This was not a site of leakage.Abrasion was noted on the inlet tube of the pump.Partial separations within abrasion were noted on the exhaust tube of cylinder 1.This was not a site of leakage.Abrasion was also noted on the exhaust tube of cylinder 2.No functional abnormalities were noted with either cylinder.No functional abnormalities were noted with the detached inlet tubing.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) may have been exerted on the longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.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, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11281276
• MDR Text Key: 230434028
• Report Number: 2125050-2021-00099
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QSR9181400
• Device Catalogue Number: QSR918
• Device Lot Number: NOT IN LIST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR