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

Catalog Number	ES8916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the device began leaking and was no longer operational.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Cylinder 1 was received for evaluation.A separation was noted on the bladder of cylinder 1.This is a site of leakage.The separation has a smooth, straight edge, indicating contact with sharp instrumentation.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the bladder of cylinder 1 occurred subsequent to the device packaging being opened.The information received indicated leak was noticed a few weeks after implantation.Based on the evaluation and information received, the separation most likely occurred inadvertently during the implant procedure.The senior research and development engineer reviewed the returned cylinder.During this review, it was concluded that the cylinder may have been damaged during implantation.It appears that a forceps or some other instrument was used to grip the tip of the cylinder to help seat the device in the corpora during surgery, which may have caused this separation noted.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information, the device began leaking and was no longer operational.No adverse effects to the patient were reported.

• 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 (Section G): MINNEAPOLIS; 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: 18324503
• Report Number: 2125050-2023-01591
• Device Sequence Number: 7520261
• Product Code: FHW
• UDI-Device Identifier: 05708932487320
• UDI-Public: 05708932487320
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/26/2026
• Device Catalogue Number: ES8916
• Device Lot Number: 7860567_ES89161022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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 Sex: Unknown