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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; MALLEABLE PENILE PROSTHESIS
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COLOPLAST A/S GENESIS MALLEABLE; MALLEABLE PENILE PROSTHESIS Back to Search Results
Model Number 5192701400
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
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 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 available information, patients experienced pain and/or infection.No other adverse patient effects were reported.
 
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Brand Name
GENESIS MALLEABLE
Common Device Name
MALLEABLE PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key11879169
Report Number2125050-2021-00623
Device Sequence Number13727963
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
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
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
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/28/2021
Initial Report FDA Received Date05/25/2021
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 Hospitalization;
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