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

Model Number QS89201000

Device Problems Material Erosion (1214); Fracture (1260)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, this device failed approximately six months ago.Upon examination, it was discovered that the tip of the right cylinder was very superficial in the glans penis.A revision was required, but was not yet scheduled.

Manufacturer Narrative

D4: lot number: 5593459.

Event Description

Additional information received further reported that once explanted, it was evident that the pump had a large, straight tear through the bottom bulbous portion of the pump.

Manufacturer Narrative

Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, may have contributed to sufficient stress(s) to separate the pump bulb 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.

Event Description

According to the available information the inflatable device was implanted in 2006 and revised on (b)(6) 2021 due to the tip of right cylinder very superficial in glans penis.Requires distal surgery on the right to correct potential erosion.Additional information noted that once explanted, it was evident that the pump had a large straight tear through the bottom bulbous portion of the pump.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11757067
• MDR Text Key: 248407456
• Report Number: 2125050-2021-00455
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• 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,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QS89201000
• Device Catalogue Number: QS8920
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR