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

Catalog Number	52060 / 450-1323
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
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.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.The additional device referenced in b5 is captured under a separate report.
Event or Problem Description
According to the available information in medsun report # (b)(4): two extra small torosa testicular prosthesis were opened for use.They both had pin holes in them in the same spot and they were from the same batch.Neither were able to be used in patient and there were no more extra smalls in stock.
Additional Manufacturer Narrative
H2: correction this is a duplicate submission due to technical difficulties that occurred with our previous follow-up submission testicular implant was received for evaluation.No functional abnormalities were noted with the torosa testicular.The information received indicated the device had a pin hole, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
Event or Problem Description
According to the available information in medsun report # 0700220000-2025-8438: two extra small torosa testicular prosthesis were opened for use.They both had pin holes in them in the same spot and they were from the same batch.Neither were able to be used in patient and there were no more extra smalls in stock.

• 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 (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24190237
• Report Number: 2125050-2026-00137
• Device Sequence Number: 7894222
• Product Code: FAF
• UDI-Device Identifier: 05708932470797
• UDI-Public: 5708932470797
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 52060 / 450-1323
• Device Lot Number: 9528759_5206002400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/20/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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