PENILE INSERTION DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-31 for PENILE INSERTION DEVICE manufactured by Ama - Coloplast Corp..

Event Text Entries

[59048125] Reporter stated that his device malfunctioned and is causing him a lot of pain. Reporter states that he is running out of money and unable to get the device explanted since he has had to pay for this device three times. He has been, and is still in pain and very frustrated as a result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065745
MDR Report Key6072149
Date Received2016-10-31
Date of Report2016-10-31
Date of Event2011-01-01
Date Added to Maude2016-11-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePENILE INSERTION DEVICE
Generic NamePENILE INSERTION DEVICE
Product CodeLKY
Date Received2016-10-31
ID NumberM1786N
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAMA - COLOPLAST CORP.
Manufacturer AddressMINNEAPOLIS MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-31

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