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

Catalog Number	519150
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, a piece of paper was found in the inner tray of the assembly kit.The product was used for the case.There were no reported adverse patient effects.
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.
Additional Manufacturer Narrative
It was reported that a piece of paper was found in the inner tray of the assembly kit.The assembly kit came from the territory manger's hci, and the product was used for the case.The device or packaging including the piece of paper was not returned, however, a picture was provided.The picture showed a small piece of paper with numbers on it.Upon review of the object by quality and production, it was not identified as something that is used or typically present in production, however the origin of the piece of paper was not able to be identified.The object was found inside the inner tray, indicates that the object may have been inadvertently introduced into the tray during device tray 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 object in question was not detected during this inspection.The packaging and qc leads have been made aware of this complaint, and the information was cascaded down to their respective teams.The addition of the small piece of paper, presents no risk to the gamma irradiation process of the product.Thin paper is a practice amongst all different types of products and packaging utilizing gamma sterilization and pose no risk to the process, or the ability for gamma rays to penetrate the sterile barrier.
Event or Problem Description
According to the available information, a piece of paper was found in the inner tray of the assembly kit.The product was used for the case.There were no reported adverse patient effects.

• 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: 19822399
• Report Number: 2125050-2024-01108
• Device Sequence Number: 8695399
• Product Code: FHW
• UDI-Device Identifier: 05701780276979
• UDI-Public: 5701780276979
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 519150
• Device Lot Number: 9448740_5191501400
• 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
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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