MAUDE Adverse Event Report: COLOPLAST A/S TOROSA SALINE-FILLED TESTICULAR PROSTHESIS; TESTICLE PROSTHESIS

Catalog Number	450-1329
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information when the testicular implant was inserted in a patient it started leaking.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.

• Brand Name: TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
• Common Device Name: TESTICLE PROSTHESIS
• 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: 18084711
• Report Number: 2125050-2023-01359
• Device Sequence Number: 6713859
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020003
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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: 450-1329
• Device Lot Number: 8658518_5206502400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Date Device Manufactured: 07/13/2022
• 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