MAUDE Adverse Event Report: EBI, LLC. ELECTRODE COVER PATCHES; ELECTRODES COVER PATCHES

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient experienced a mild rash while treating with the device.The patient was not sure if the rash was from 72r electrodes or cover patches.The patient states that her skin was very itchy.She changed them every 2 to 3 days, states rotates the position on her skin.The patient wears 72r electrodes and cover patches on her neck.The patient's doctor advised her to use (b)(6) on area.The patient will take a break in treatment until her skin is completely healed.Afterwards, she conduct time test with 63b electrodes.The patient was sent replacement 63b electrodes.It was reported that no further information is available.

Manufacturer Narrative

The device was returned to zimmer biomet and the investigation is complete.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after review of the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.

Manufacturer Narrative

Corrections: b4 date of this report added, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, g1 contact office, and manufacturer site, g6 type of report , h10 updated vice history record/certificate of conformance.Additional information: h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of conformance was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.

Event Description

It was reported that the patient experienced a mild rash while treating with the device.The patient was not sure if the rash was from 72r electrodes or cover patches.The patient states that her skin was very itchy.She changed them every 2 to 3 days, states rotates the position on her skin.The patient wears 72 electrodes and cover patches on her neck.The patient's doctor advised her to use hydrocortisone cream on area.The patient will take a break in treatment until her skin is completely healed.Afterwards, she conduct time test with 63b electrodes.The patient was sent replacement 63b electrodes.It was reported that no further information is available.It was reported that no further information is available.The cover patches were not returned for evaluation.

Manufacturer Narrative

Corrections: b4 date of this report added, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, g1 contact office, and manufacturer site, g6 type of report additional information: h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of compliance was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.

Event Description

It was reported that the patient experienced a mild rash while treating with the device.The patient was not sure if the rash was from 72r electrodes or cover patches.The patient states that her skin was very itchy.She changed them every 2 to 3 days, states rotates the position on her skin.The patient wears 72 electrodes and cover patches on her neck.The patient's doctor advised her to use hydrocortisone cream on area.The patient will take a break in treatment until her skin is completely healed.Afterwards, she conduct time test with 63b electrodes.The patient was sent replacement 63b electrodes.It was reported that no further information is available.It was reported that no further information is available.The cover patches were not returned for evaluation.

Event Description

It was reported that the patient experienced a mild rash while treating with the device.The patient was not sure if the rash was from 72r electrodes or cover patches.The patient states that her skin was very itchy.She changed them every 2 to 3 days, states rotates the position on her skin.The patient wears 72 electrodes and cover patches on her neck.The patient's doctor advised her to use hydrocortisone cream on area.The patient will take a break in treatment until her skin is completely healed.Afterwards, she conduct time test with 63b electrodes.The patient was sent replacement 63b electrodes.It was reported that no further information is available.It was reported that no further information is available.The cover patches were not returned for evaluation.

Manufacturer Narrative

Corrections: b4 date of this report added, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, g1 contact office, and manufacturer site, g6 type of report , h10 updated vice history record/certificate of conformance, h2 device manufacture date.Additional information: h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of conformance was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.

Event Description

It was reported that the patient experienced a mild rash while treating with the device.The patient was not sure if the rash was from 72r electrodes or cover patches.The patient states that her skin was very itchy.She changed them every 2 to 3 days, states rotates the position on her skin.The patient wears 72 electrodes and cover patches on her neck.The patient's doctor advised her to use hydrocortisone cream on area.The patient will take a break in treatment until her skin is completely healed.Afterwards, she conduct time test with 63b electrodes.The patient was sent replacement 63b electrodes.It was reported that no further information is available.It was reported that no further information is available.The cover patches were not returned for evaluation.

Manufacturer Narrative

Corrections: b4 date of this report added, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, g1 contact office, and manufacturer site, g6 type of report , h10 updated vice history record/certificate of conformance, h2 device manufacture date, h6 method.Additional information: h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of conformance was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.

• Brand Name: ELECTRODE COVER PATCHES
• Type of Device: ELECTRODES COVER PATCHES
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12969030
• MDR Text Key: 283308627
• Report Number: 0002242816-2021-00223
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022/S017
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 106130-17
• Device Lot Number: 115141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/23/2024; 05/24/2024; 05/24/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic