MAUDE Adverse Event Report: EBI, LLC. ELECTRODE COVER PATCHES; STIMULATOR, SPINAL PAK, NON-INVASIVE (ELECTRODE COVER PATCHES)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint cmp (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient developed a skin reaction while using the 72r electrodes and/or cover patches.The patient wore electrodes and cover patches for 10 hours and changed them everyday.The electrodes were rotated with the cover patches because of irritation.She has sensitive skin.The patient used the electrodes with a regular band-aid, less irritation.The patient believes it's the covers.The patient did not seek medical intervention.Instead, she used cortisone cream and itch relief lotion.Has sensitive skin.Zimmer biomet sent the patient 63b electrodes.The patient later reported that the 63b electrodes caused burning, itching, swelling and welts.The patient used over the counter benadryl but it did not work.She takes blood pressure medication.The patient's doctor told her that she did not need to use the product if it was causing problems.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.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 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 zimvie will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.D4 unique identifier (udi) number updated.G1: contact office updated.G3: date received by manufacturer added.G6: type of report updated.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: component codes added 772 - cover.H6: impact code added 4648-insufficient information.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient developed a skin reaction while using the 72r electrodes and/or cover patches.The patient wore electrodes and cover patches for 10 hours and changed them everyday.The electrodes were rotated with the cover patches because of irritation.She has sensitive skin.The patient used the electrodes with a regular band-aid, less irritation.The patient believes it's the covers.The patient did not seek medical intervention.Instead, she used cortisone cream and itch relief lotion.Has sensitive skin.Zimmer biomet sent the patient 63b electrodes.The patient later reported that the 63b electrodes caused burning, itching, swelling and welts.The patient used over the counter benadryl but it did not work.She takes blood pressure medication.The patient's doctor told her that she did not need to use the product if it was causing problems.

• Brand Name: ELECTRODE COVER PATCHES
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (ELECTRODE COVER PATCHES)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12248988
• MDR Text Key: 265910806
• Report Number: 0002242816-2021-00127
• 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
• 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
• Report Date: 04/05/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-17
• Device Lot Number: 031440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female