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

Catalog Number	450-1329
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the patient experienced scrotal swelling 2 weeks post implant.The ct showed there was an 11 cm fluid collection in the right hemiscrotum.The physician ended up removing the testicular implant due to the patient developing a fever.It was noted the hematoma ended up being infected.
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 in veeva to be associated.G3: estimated date.

• Brand Name: TOROSA SALINE-FILLED TESTICULAR PROSTHESIS
• Common Device Name: Prosthesis, testicular
• 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: 19448988
• Report Number: 2125050-2024-00839
• Device Sequence Number: 3239958
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 5708932470858
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/03/2024

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: Health Professional
• Device Catalogue Number: 450-1329
• Device Lot Number: 9243343_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: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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: 33 YR
• Patient Sex: Male