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U.S. Department of Health and Human Services

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

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COLOPLAST A/S (OUT) TITAN OTR SCROTAL INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QSR9181750
Device Problems Break; Leak / Splash; Material Rupture
Event Date 11/13/2018
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 patient had no fluid left in the system. A tear was found in the tubing under the cylinders when examined.

 
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Brand Name(OUT) TITAN OTR SCROTAL
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 Key8157070
Report Number2125050-2018-00875
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 03/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQSR9181750
Device Catalogue NumberQSR918
Device LOT Number1759260
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/14/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
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

Patient TREATMENT DATA
Date Received: 12/12/2018 Patient Sequence Number: 1
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