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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES28202400
Device Problems Tube (525); Break (1069)
Patient Problem No Information (3190)
Event Date 03/09/2018
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. Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

 
Event Description

According to the available information, tubing break.

 
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Brand NameTITAN TOUCH INFR 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 river road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west rivier road north
minneapolis, MN 55411
6123578517
MDR Report Key7381813
MDR Text Key103833895
Report Number2125050-2018-00266
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
PMA/PMN NumberP000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES28202400
Device Catalogue NumberES28202400
Device LOT Number3951058
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/09/2018
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

Patient TREATMENT DATA
Date Received: 03/29/2018 Patient Sequence Number: 1
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