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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC TITAN TOUCH NB INFR ZERO 14CM; INFLATABLE PENILE PROSTHESIS
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COLOPLAST MANUFACTURING US, LLC TITAN TOUCH NB INFR ZERO 14CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number EN28142400
Health Effect - Clinical Code No Information (3190)
Date of Event 11/07/2017
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
According to the available information, 14cm titan touch was explanted because it was too short.Patient was revised with 20cm titan touch.
 
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Brand Name
TITAN TOUCH NB INFR ZERO 14CM
Common Device Name
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
MDR Report Key7061071
Report Number2125050-2017-00583
Device Sequence Number13845820
Product Code FHW
UDI-Device Identifier05708932539074
UDI-Public05708932539074
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberEN28142400
Device Catalogue NumberEN28142400
Device Lot Number4028728
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2017
Initial Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age71 YR
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