REGARD DEFIBRILLATOR ELECTRODES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for REGARD DEFIBRILLATOR ELECTRODES manufactured by Resource Optimization & Innovation, L.l.c..

Event Text Entries

[125462287] While taking off defibrillator pad after surgery, and mindful of keeping patient's skin integrity intact, i was slowly peeling off the defibrillator pad on right lateral side, but some skin still peeled off measuring approximately 1 inch x 0. 25 inch. Physicians assistant and doctors were aware. Applied neomycin ointment to area. Since the conversion to the "regard" defibrillator pad in question, a sudden increase in skin tears have been noted. All cases reviewed, education completed by company representative to cardiovascular operating room team members and appropriate removal technique reviewed. I would also like to note, this pad is utilized along with a warming blanket, known as the blanketrol, to maintain patient temperature. Discussions with company rep have arose regarding the possibility of increased tackiness to the pad in production, as well as an increase in tackiness due to the blanketrol heat pad being used. Both theories are being reviewed. Regard defibrillator pad.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8018544
MDR Report Key8018544
Date Received2018-10-30
Date of Report2018-10-25
Date of Event2018-07-20
Report Date2018-10-25
Date Reported to FDA2018-10-25
Date Reported to Mfgr2018-10-30
Date Added to Maude2018-10-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREGARD DEFIBRILLATOR ELECTRODES
Generic NameELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
Product CodeMLN
Date Received2018-10-30
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Manufacturer Address3000 E SAWYER RD REPUBLIC MO 65738 US 65738


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-30

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