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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENESIS MALLEABLE; PENILE PROTHESIS

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GENESIS MALLEABLE; PENILE PROTHESIS Back to Search Results
Model Number 5192601400
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Type  Injury  
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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
According to the available information, though not verified, revision case scheduled for (b)(6) 2021.The prosthesis appears eroded through the cc tips with impending erosion into urethra and through glans.
 
Manufacturer Narrative
A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.The review of the device lot history record indicates this lot was processed through the validated sterilization cycle.Therefore, it was concluded the infection originated from source(s) other than the device.
 
Event Description
Additional information received further reported that an infection also occurred.The explant of the device was successful.Revision surgery has been scheduled for (b)(6) 2021 to re-insert a malleable prosthesis now that the patient has had time to recover from the infection.
 
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Brand Name
GENESIS MALLEABLE
Type of Device
PENILE PROTHESIS
MDR Report Key11121846
MDR Text Key225247616
Report Number2125050-2021-00017
Device Sequence Number1
Product Code FAE
UDI-Device Identifier05708932324748
UDI-Public05708932324748
Combination Product (y/n)N
PMA/PMN Number
K040959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/13/2021
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 Health Professional
Device Model Number5192601400
Device Catalogue Number519260
Device Lot Number3079593
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received01/06/2021
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received08/13/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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