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 2020-01-23 for ELECTRODE COVER PATCHES N/A 106130-17 manufactured by Ebi, Llc..

Event Text Entries

[188861135] Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2020. Medical product: spinalpak assembly catalog: #1066716 serial: # (b)(4). Therapy date: unknown. The customer has indicated that the product is in the 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: 0002242816-2020-00011. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10


[188861136] It was reported that the patient experienced skin irritation from using the 63b electrodes and the cover patches on his lower back. The patient stated that he did not have any pain, the skin was just very itchy. The skin became very raw and would bleed. The patient did contact his doctor who advised the patient to discontinue use of the unit. The patient reported that since he stopped using the device all that he has left is a little bit of a scab. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002242816-2020-00010
MDR Report Key9621512
Report SourceCONSUMER
Date Received2020-01-23
Date of Report2020-01-22
Date Mfgr Received2020-01-06
Date Added to Maude2020-01-23
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 Received2020-01-23
Model NumberN/A
Catalog Number106130-17
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
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 2020-01-23

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