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

Catalog Number	450-1329
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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.
Event or Problem Description
According to the available information, after prepping the device, the device was placed and an initial in situ assessment for fit and feel was performed.The device was then removed from the patient, and at this point the physician noticed a small pinhole defect in the side of the implant.The hole was roughly 1/3rd of the way down the side of the implant.The physician believed, given the location of the hole, that there was no way he could've punctured the implant during prep or placement, as the butterfly needle tip did not come close to the location of the hole.A new implant was opened to complete the case.
Event or Problem Description
According to the available information, after prepping the device, the device was placed and an initial in situ assessment for fit and feel was performed.The device was then removed from the patient, and at this point the physician noticed a small pinhole defect in the side of the implant.The hole was roughly 1/3rd of the way down the side of the implant.The physician believed, given the location of the hole, that there was no way he could've punctured the implant during prep or placement, as the butterfly needle tip did not come close to the location of the hole.A new implant was opened to complete the case.
Additional Manufacturer Narrative
Testicular implant was received for evaluation.A separation was noted in the shell of the testicular implant.This was a site of leakage.The separation appeared to have a central groove, indicating contact with sharp instrumentation such as a needle because this component was released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the testicular shell occurred subsequent to the device packaging being opened.The testicular device was returned with saline inside.Based on the evaluation and information received, it was concluded that the separation most likely occurred inadvertently during the filling of the device prior to implant.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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21001095
• Report Number: 2125050-2024-02148
• Device Sequence Number: 20502725
• Product Code: FAF
• UDI-Device Identifier: 05708932470858
• UDI-Public: 05708932470858
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 9766661_5206502400
• 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
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Male