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

Catalog Number	519310
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
Event or Problem Description
According to the available information the rear tip extender kit was found with a foreign object inside the sterile packaging.The device was immediately taken off the field and not used.
Event or Problem Description
According to the available information the rear tip extender kit was found with a foreign object inside the sterile packaging.The device was immediately taken off the field and not used.
Additional Manufacturer Narrative
It was reported that a foreign object that looked like either a white hair or a shaving discarded from plastic molding was found inside the rte packaging on the tray retainer.The unit was removed from the sterile field immediately upon the discovery of a foreign object, so the device was not implanted.The unit was sent back for evaluation.The unit was inspected upon receipt to characterize the foreign material.The object appears to be a plastic monofilament with glue on the bottom.Ftir conducted on the filament indicated it was a zein polymer, likely from a clothing fabric, but the exact origin of the monofilament could not be confirmed.The object was found inside the sterile packaging which indicates that the object may have been inadvertently introduced into the tray during the device packaging.All units are continuously inspected by the packaging operators and 100% inspected by qc following tray sealing per vv-0199806 - packaged product inspection.In this case, the fiber in question was not detected during the inspection.The packaging and qc leads have been made aware of this complaint, and the information was cascaded down to their respective teams.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES
• 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: 19690019
• Report Number: 2125050-2024-00993
• Device Sequence Number: 12792716
• Product Code: FHW
• UDI-Device Identifier: 05701780277006
• UDI-Public: 05701780277006
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 519310
• Device Lot Number: 9638521_5193101400
• Is the Reporter a Health Professional?: Yes
• 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: 07/08/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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
• Patient Sex: Unknown