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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (OUT)TITAN OTR SCROTAL 18CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (OUT)TITAN OTR SCROTAL 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QSR9181002
Device Problems Cylinder (440); Tube (525); Break (1069)
Patient Problem No Information (3190)
Event Date 12/28/2016
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 occurence. 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. (b)(4).

 
Event Description

According to the available information, break of tube of cylinder.

 
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Brand Name(OUT)TITAN OTR SCROTAL 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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6740825
MDR Text Key80936800
Report Number2125050-2017-00211
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 FOREIGN,HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQSR9181002
Device Catalogue NumberQSR9181002
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/13/2017
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: 07/25/2017 Patient Sequence Number: 1
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