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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29162400
Device Problem Material Rupture
Event Type  Injury  
Manufacturer Narrative

The device has been received at coloplast; however the evaluation is not yet complete. 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 experienced tubing fracture. Additional information received indicated the pump remains dimpled after pumping once or twice, indicating fluid loss in system. Upon removal, proximal tubing break observed.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 16CM
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 Key8111790
Report Number2125050-2018-00841
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29162400
Device Catalogue NumberES2916
Device LOT Number4287680
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
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: 11/28/2018 Patient Sequence Number: 1
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