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U.S. Department of Health and Human Services

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

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COLOPLAST A/S (OUT)TITAN SCROTAL RESIST 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89181000
Device Problems Tube (525); Break (1069)
Patient Problem No Information (3190)
Event Date 06/12/2017
Event Type  Injury  
Manufacturer Narrative

A titan pump, two cylinders and lockout reservoir were received for evaluation. Examination and testing of the returned components revealed a separation through the serialized strain relief tube. Testing revealed this to be a site of leakage. Quality concluded that the rough and irregular surface associated with this separation indicates sufficient stress(s) was exerted to separate the site while in-vivo. A separation of this type would then allow the loss of fluid, making the device inoperable. Management routinely reviews events such as this and monitors complaint levels. Additionally, events of this type relating to tubing break are captured in the product risk documentation and are addressed in the literature that accompanies the device. Based on this no further corrective action is required at this time. (b)(4).

 
Event Description

According to the available information, clear tubing break.

 
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Brand Name(OUT)TITAN SCROTAL RESIST 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 Key6740816
MDR Text Key80935082
Report Number2125050-2017-00209
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
Type of Report Initial
Report Date 07/20/2017
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 NumberQS89181000
Device Catalogue NumberQS89181000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated By Manufacturer? Yes
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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