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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN SCROTAL RESIST 22CM INFLATABLE PENILE PROSTHESIS

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COLOPLAST A/S (2BO)TITAN SCROTAL RESIST 22CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89221000
Device Problems Tube (525); Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 07/13/2017
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, a malfunction occurred and broken tubing.

 
Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device. A titan pump and two cylinders were received for evaluation. Examination and testing of the returned components revealed a separation on the top to the pump bulb. Testing revealed this to be a site of leakage. The detachment site of the shorter exhaust tube of the pump and of the exhaust tube of cylinder #2 appear to be rough and irregular. Quality concluded that the rough and irregular surfaces associated with these detachment sites indicate that sufficient stress(s) may have been exerted on the exhaust tube of cylinder #2 and the non-serialized exhaust tube of the pump. The rough and irregular surfaces associated with the separation on the top of the pump bulb indicates sufficient stress may also have been exerted to separate the site while in-vivo. Separations of this type could then allow the loss of fluid, making the device inoperable. However, as additional information was not received, quality is unable to determine if only one or both sites were the cause for the reported failure. Management routinely reviews events such as this and monitors complaint levels. Additionally, events of this type are captured in the product risk documentation. Based on this information, no further corrective action is required at this time.

 
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Brand Name(2BO)TITAN SCROTAL RESIST 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 river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6807001
MDR Text Key83124653
Report Number2125050-2017-00361
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,OTHER
Type of Report Initial,Followup,Followup
Report Date 12/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQS89221000
Device Catalogue NumberQS89221000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/21/2017 Patient Sequence Number: 1
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