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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN SCROTAL 20CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (2BO)TITAN SCROTAL 20CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89201400
Device Problems Tube (525); Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 07/27/2017
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, there was a device malfunction. There was a break in the tubing.

 
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Brand Name(2BO)TITAN SCROTAL 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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6813621
MDR Text Key83383968
Report Number2125050-2017-00366
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 OTHER
Type of Report Initial
Report Date 08/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQS89201400
Device Catalogue NumberQS89201400
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/23/2017 Patient Sequence Number: 1
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