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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (OUT)TITAN SCROTAL RESIST 20 INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (OUT)TITAN SCROTAL RESIST 20 INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89201000
Device Problem Material Rupture
Event Date 10/04/2018
Event Type  Injury  
Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Once our evaluation is complete, a follow-up report will be submitted.

 
Event Description

According to the available information, the device was explanted due to cracked tubing close to pump.

 
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Brand Name(OUT)TITAN SCROTAL RESIST 20
Type of DeviceINFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west rivier road north
minneapolis , MN 55411
6124345685
MDR Report Key8041825
Report Number2125050-2018-00796
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQS89201000
Device Catalogue NumberQS8920
Device LOT Number1951544
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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