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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S GENESIS KIT 13 COATED; PENILE PROSTHESIS
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COLOPLAST A/S GENESIS KIT 13 COATED; PENILE PROSTHESIS Back to Search Results
Model Number 5192701400
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/29/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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 or Problem Description
According to the available information, a malleable device was used for spacers.The device was explanted and replaced with an inflatable prosthesis.
 
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Brand Name
GENESIS KIT 13 COATED
Common Device Name
PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA  3050
MDR Report Key9566777
Report Number2125050-2020-00013
Device Sequence Number2196751
Product Code FAE
UDI-Device Identifier05708932324809
UDI-Public05708932324809
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K040959
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/02/2020
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 Number5192701400
Device Catalogue Number519270
Device Lot Number5078847
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2019
Initial Report FDA Received Date01/08/2020
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 Age46 YR
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