MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B; STIMULATOR, SPINAL PAK, NON-INVASIVE (63B ELECTRODES)

Model Number N/A

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

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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 complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that he patient was experiencing skin irritation while using the 63b electrodes.She says it was worse than the 72r electrodes.The patient describes the skin as very red and itchy.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 not 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 d4: additional device information update d4 additional device information: added udi# g1-2: contact office updated g3: date received by manufacturer added g6: type of report h2: follow up type h3: device evaluated by manufacturer updated to no h4: device manufacturer date added h6: clinical code updated 1943: itching sensation added h6: clinical code updated 2146: burning sensation added h6: clinical code updated 4577: swelling/edema added h6 type of investigation: 3331 - analysis of production records h6 type of investigation: 4114 - device not returned h6: investigation findings code added to 3221: no findings available h10: additional narratives/data the following sections have been corrected: h6: component code: 451-electrode h6: type of device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient was experiencing skin irritation while using the 63b electrodes.She says it was worse than the 72r electrodes.The patient describes the skin as very red and itchy.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: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (63B ELECTRODES)
• 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: 12250097
• MDR Text Key: 264274093
• Report Number: 0002242816-2021-00128
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• 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: 09/28/2022

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: 106130-22
• Device Lot Number: 020001
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female