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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN SCROTAL RESIST 18CM INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QS89181000
Device Problem Material Rupture
Event Date 09/12/2019
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 or 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, ruptured cylinder tubing from 2008 implant. The device was explanted and replaced with another inflatable device.

 
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Brand NameTITAN SCROTAL RESIST 18CM
Type of DeviceINFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S
holtedam 1
humlebaek, MN 3050
DA  3050
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis , MN 55411
6122196218
MDR Report Key9281629
Report Number2125050-2019-00956
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberQS89181000
Device Catalogue NumberQS8918
Device LOT Number5719790
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 11/05/2019 Patient Sequence Number: 1
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