FHC 5005L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-18 for FHC 5005L manufactured by Fhc.

Event Text Entries

[34325146] Microtargeting electrodes were faulty and causing impedances. Removed from surgical field and replaced. Faulty devices prolonged the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058697
MDR Report Key5324372
Date Received2015-12-18
Date of Report2015-12-18
Date of Event2015-11-04
Date Added to Maude2015-12-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameFHC
Generic NameMICROTARGETING ELECTRODES
Product CodeGZL
Date Received2015-12-18
Returned To Mfg2015-12-21
Model Number5005L
Catalog Number5005L
Lot Number211561
Device Expiration Date2018-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerFHC
Manufacturer Address1201 MAIN STREET BOWDOIN ME US

Device Sequence Number: 2

Brand NameFHC
Generic NameMICROTARGETING ELECTRODES
Product CodeGZL
Date Received2015-12-18
Model Number66-IT-300
Catalog Number66-IT-300
Lot Number211743
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerFHC
Manufacturer Address1201 MAIN STREET BOWDOIN ME US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-12-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.