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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TOROSA SALINE-FILLED TESTICULAR PROSTHESIS; Prosthesis, testicular
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COLOPLAST A/S TOROSA SALINE-FILLED TESTICULAR PROSTHESIS; Prosthesis, testicular Back to Search Results
Catalog Number 450-1329
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/20/2024
Type of Reportable Event Serious Injury
Event or Problem Description
According to the available information the device was explanted and replaced due to patient preference.The patient felt that the implant was positioned too high inside the scrotum.
 
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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 Key18925112
Report Number2125050-2024-00431
Device Sequence Number4579765
Product Code FAF
UDI-Device Identifier05708932470858
UDI-Public05708932470858
Combination Product (Y/N)N
PMA/510(K) Number
P020003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/18/2024
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? Yes
Operator of Device Lay User/Patient
Device Catalogue Number450-1329
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/18/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
Patient SexMale
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