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

Catalog Number ES8922

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  Injury  

Event Description

According to the available information the device was explanted and replaced due to the pump broke at the ball.

Event Description

According to the available information the device was explanted and replaced due to the pump broke at the ball.

Manufacturer Narrative

Titan pump was received for evaluation.A separation was noted on the body of the pump.This is a site of leakage.The surfaces appear to be non-striated, dull, and smooth, indicating that sufficient stress(s) was exerted.Based on examination of the returned product, it was concluded that the non-striated, dull, and smooth surfaces associated with the separation indicate that sufficient stress was exerted on the pump bulb.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, and nonconformances revealed no trends for this lot.The lot number was found to be associated to (b)(4).

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18518621
• MDR Text Key: 332933972
• Report Number: 2125050-2024-00084
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2024
• Device Catalogue Number: ES8922
• Device Lot Number: 6891549_ES89222400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male