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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29222400
Device Problem Short Fill
Event Date 11/02/2018
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, not enough fluid in reservoir, added 40cc. Device remains implanted.

 
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Brand NameTITAN TOUCH SCRO ZERO ANG 22CM
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 Key8157066
Report Number2125050-2018-00885
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29222400
Device Catalogue NumberES2922
Device LOT Number6121960
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
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: 12/12/2018 Patient Sequence Number: 1
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