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

Catalog Number	450-1327
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the customer requested to remove the damaged device.The left scrotum was shrunken; palpation revealed a hard, deformed object inside the scrotum.An incision was made along the anterior midline of the left scrotum, approximately 3 cm in length.Dissection was carried through the skin and muscle layers into the left tunica vaginalis cavity.A large amount of clear yellow fluid was observed.One silicone object, soft and pliable, resembling a compressed artificial testicle, was removed from the left tunica vaginalis.The device was explanted and replaced due to a possible leak through a needle puncture site after filling.
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.
Event or Problem Description
According to the available information the customer requested to remove the damaged device.The left scrotum was shrunken; palpation revealed a hard, deformed object inside the scrotum.An incision was made along the anterior midline of the left scrotum, approximately 3 cm in length.Dissection was carried through the skin and muscle layers into the left tunica vaginalis cavity.A large amount of clear yellow fluid was observed.One silicone object, soft and pliable, resembling a compressed artificial testicle, was removed from the left tunica vaginalis.The device was explanted and replaced due to a possible leak through a needle puncture site after filling.
Additional Manufacturer Narrative
H2: correction.This is a duplicate submission due to technical difficulties that occurred with our previous follow-up submission the information received indicated the device had a leakage through the needle puncture site after filling, 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.

• 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: 24304165
• Report Number: 2125050-2026-00227
• Device Sequence Number: 13129397
• Product Code: FAF
• UDI-Device Identifier: 05708932470834
• UDI-Public: 5708932470834
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 450-1327
• Device Lot Number: 9868391_5206302400
• 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: 02/10/2026
• Supplement Report FDA Received Date: 04/20/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Unknown