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U.S. Department of Health and Human Services

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

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COLOPLAST A/S TITAN SCROTAL ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number ES89182400
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/17/2017
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, titan was explanted due to broken tubing to pump.
 
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Brand Name
TITAN SCROTAL ZERO ANG 18CM
Type of Device
INFLATABLE 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 Key7068897
MDR Text Key93284823
Report Number2125050-2017-00599
Device Sequence Number1
Product Code FHW
UDI-Device Identifier05708932487344
UDI-Public05708932487344
Combination Product (y/n)N
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberES89182400
Device Catalogue NumberES89182400
Device Lot Number4561204
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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