MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B

Model Number N/A

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

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: the event occurred sometime in february 2023.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

The patient reported that the 63b electrodes irritated her skin, the skin was red and itchy.The patient did not do the time test and stated that she spoke to her doctor and that the doctor told her to discontinue the use of the bone growth stimulator.

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: h3: device evaluated by manufacturer updated to yes h6: component codes added 451 - electrode h6: clinical code added 4545 - skin inflammation/ irritation h6: clinical code added 1943 - itching sensation h6: device code updated to 2682 - patient-device incompatibility h6: investigation code added to 3331 - analysis of production records h6: investigation code added to 4119 ¿ insufficient information available h6: investigation findings code added to 3221: no findings available h6: investigation conclusions added to 4315 - cause not established the following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

The patient reported that the 63b electrodes irritated her skin, the skin was red and itchy.The patient did not do the time test and stated that she spoke to her doctor and that the doctor told her to discontinue the use of the bone growth stimulator.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: 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: 16499335
• MDR Text Key: 310852747
• Report Number: 0002242816-2023-00022
• 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: 05/10/2023

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: 106130-22
• Device Lot Number: 132301
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 74 YR
• Patient Sex: Female