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

Catalog Number	450-1327
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the patient had a torosa implanted on (b)(6) 2024.During the surgery, a medium-sized implant was placed.The patient is experiencing both physical discomfort and concern regarding product compliance.The surgery report the patient received indicates that the implant was filled with 16cc's of saline but the patient believes the maximum recommended fill limit for a medium implant does not exceed 15cc's.Currently, the implant is rigid, abnormally heavy, and three times the size of the patient's remaining testicle, causing substantial physical and psychological distress.In follow-up with the doctor, the patient was advised only 4 cc's had been used.A photo of the surgery report referenced by the patient shows the implant sticker which references 16cc for a medium torosa.
Additional Manufacturer Narrative
A label review was performed and confirmed the correct volume (16cc) was referenced for a saline-filled testicular prosthesis, size medium.The device history record was also reviewed and confirmed that molded torosa shells used to manufacture this finished good lot were of the correct size.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: 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: 20622446
• Report Number: 2125050-2024-01820
• Device Sequence Number: 12650543
• Product Code: FAF
• UDI-Device Identifier: 05708932470834
• UDI-Public: 05708932470834
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: Lay User/Patient
• Device Catalogue Number: 450-1327
• Device Lot Number: 9619734_5206302400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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 Age: 41 YR
• Patient Sex: Male