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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 16CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES28162400
Device Problems Tube (525); Material Twisted/Bent (2981); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 07/17/2018
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 revised because the tubing for the pump was twisted. The problem was corrected and all works fine.

 
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Brand NameTITAN TOUCH INFR 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 Key7756585
MDR Text Key116226732
Report Number2125050-2018-00586
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,HEALTH
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES28162400
Device Catalogue NumberES2816
Device LOT Number5533048
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/07/2018 Patient Sequence Number: 1
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