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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH INFR ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES28181022
Device Problems Inflation Problem; Inadequacy of Device Shape and/or Size; Free or Unrestricted Flow
Event Type  Injury  
Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report nor has the device been received for evaluation. A review of the device history record confirmed the devices from this lot met all specifications prior to release. A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

 
Event Description

According to the initial available information, this inflatable penile prosthesis was implanted on (b)(6) 2017. The device was checked during the implant procedure and inflation/deflation was confirmed. Following implantation, after inflation and complete deflation, 3/5ml was left in the cylinders and therefore the cylinders are slightly inflated and do not become flat again. Additional information received noted a revision surgery on (b)(6) 2017, and stated the device "spontaneously re-inflates in semi-erection. ".

 
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Brand NameTITAN TOUCH INFR ZERO ANG 18CM
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
lauren prioleau
1601 west river road north
minneapolis , MN 55411
6122196218
MDR Report Key9298155
Report Number2125050-2019-00971
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES28181022
Device Catalogue NumberES2818
Device LOT Number4726113
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
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: 11/08/2019 Patient Sequence Number: 1
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