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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S TITAN NARROW SCROT 16CM; INFLATABLE PENILE PROSTHESIS
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COLOPLAST A/S TITAN NARROW SCROT 16CM; INFLATABLE PENILE PROSTHESIS Back to Search Results
Model Number QN89161400
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/29/2017
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, the pump tubing frayed and leaks.
 
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Brand Name
TITAN NARROW SCROT 16CM
Common Device Name
INFLATABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key6882873
Report Number2125050-2017-00437
Device Sequence Number10904340
Product Code FHW
UDI-Device Identifier05708932323604
UDI-Public05708932323604
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/19/2017
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 NumberQN89161400
Device Catalogue NumberQN89161400
Device Lot Number5491300
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 09/07/2017
Initial Report FDA Received Date09/21/2017
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 Age52 YR
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