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

Catalog Number	ES2816
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.
Event or Problem Description
According to the available information, the device was explanted and replaced due to an unknown malfunction.
Event or Problem Description
According to the available information, the device was explanted and replaced due to an unknown malfunction.
Additional Manufacturer Narrative
Titan touch pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.A separation was noted on the bladder of cylinder 1.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.A separation was noted on the bladder of cylinder 2.This is a site of leakage.The separation has a central groove, indicating contact with sharp instrumentation such as a needle.A group of striations, indicating contact with unshod instrumentation, was noted on the inlet tube of the pump.This is a site of leakage.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation indicates that sufficient stress was exerted on the bladder of cylinder 1 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 INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: 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: 19782378
• Report Number: 2125050-2024-01060
• Device Sequence Number: 8181212
• Product Code: FHW
• UDI-Device Identifier: 05708932539111
• UDI-Public: 05708932539111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/08/2022
• Device Catalogue Number: ES2816
• Device Lot Number: 5954042_ES28161022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male