ELECTRODE COVER PATCHES N/A 106130-17

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-05 for ELECTRODE COVER PATCHES N/A 106130-17 manufactured by Ebi, Llc..

Event Text Entries

[169205721] (b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: spinalpak assembly: serial # (b)(4), catalog #1067716. Therapy date: unknown. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2019-00043, 0002242816-2019-00045, 0002242816-2019-00046. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10


[169205722] It was reported that the patient experienced skin irritation from using the electrodes and cover patches for the spinalpak. The patient said that the skin was red and itchy with little bumps and scabs. The patient said that the skin irritation was painful. The patient tried to break up her treatment time and use different electrodes but the skin irritation still occurred. The patient contacted her doctor who advised her to stop using the spinalpak. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002242816-2019-00044
MDR Report Key9415367
Report SourceCONSUMER
Date Received2019-12-05
Date of Report2020-03-17
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-03-25
Date Added to Maude2019-12-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactSARA DAILEY
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal07054
Manufacturer Phone9732999300
Manufacturer G1EBI, LLC.
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal Code07054
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameELECTRODE COVER PATCHES
Generic NameCOVER PATCHES
Product CodeLOF
Date Received2019-12-05
Model NumberN/A
Catalog Number106130-17
Lot Number909501
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEBI, LLC.
Manufacturer Address399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-12-05

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