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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; PENILE PROSTHESIS

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COLOPLAST A/S GENESIS MALLEABLE; PENILE PROSTHESIS Back to Search Results
Model Number 5192601022
Device Problem Material Erosion (1214)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and 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 Description
According to the available information, although not verified, this device was explanted due to erosion distally.The device was not replaced due to the patient's age and the status of his health.No other adverse patient effects were reported.
 
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Brand Name
GENESIS MALLEABLE
Type of Device
PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usjki jennifer kinneman
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11693345
MDR Text Key246252747
Report Number2125050-2021-00391
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/20/2021
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
Device Operator Lay User/Patient
Device Expiration Date10/17/2020
Device Model Number5192601022
Device Catalogue Number519260
Device Lot Number4859664
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/20/2021
Date Device Manufactured11/25/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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