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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29202400
Device Problem Material Rupture
Event Date 10/12/2018
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 a tubing break in clear tubing from pump to cylinder (broken slightly above thick tubing). The other clear tubing on the opposite side and the black tubing look worn.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 20CM
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
sarah o'gara
1601 west rivier road north
minneapolis , MN 55411
6123578517
MDR Report Key8041824
Report Number2125050-2018-00794
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Type of Report Initial,Followup,Followup
Report Date 05/29/2019
1 Device Was Involved in the Event
1 Patient Was 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 NumberES29202400
Device Catalogue NumberES2920
Device LOT Number3951064
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/04/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2018
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: 11/06/2018 Patient Sequence Number: 1
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