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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES29182400
Device Problems Tube (525); Break (1069); Fluid Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 04/26/2017
Event Type  Injury  
Manufacturer Narrative

A titan touch pump was received for evaluation. Examination and testing of the returned pump revealed the inlet and exhaust tubes of the pump had twisted and overlapped while in-vivo. This positioning, combined with device usage over time most likely contributed to sufficient stress(s) to cause a separation through the longer exhaust tube of the pump. 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 fluid loss 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. See attached letter from fda dated 06/23 indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(4) program. Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.

 
Event Description

According to the available information: malfunction - fluid loss - tubing break between cylinder and pump.

 
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Brand NameTITAN TOUCH SCRO 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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6739122
MDR Text Key80864497
Report Number2125050-2017-00291
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 07/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberES29182400
Device Catalogue NumberES29182400
Device LOT Number4413939
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/02/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2017
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: 07/24/2017 Patient Sequence Number: 1
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