MAUDE Adverse Event Report: EBI, LLC. SFLX 4 COIL; BHS NON-INVASIVE STIMULATOR (COIL)

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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 or Problem Description
It was reported that the patient is complaining about the bhs unit and would like to switch the patient to an ortho pak.The patient stated she cannot wear the unit as the coil is falling off her foot.The patient was placing the coil underneath her sock, which was "hurting her bunion." the patient is treating the 5th met.The patient did not contact the doctor.The patient will be switched to an opak, and the bhs assembly and coils will be returned.A return label has been sent to the patient.
Additional Manufacturer Narrative
Corrections - b4: date of this report added, b5: updated the product was not returned for evaluation, d3: manufacturer address and email address, d4: udi, d9: device not available for evaluation, g1: contact office and manufacturer site, g6: report type additional information - h4: device manufacture date, h6: impact code, method, results, and conclusions, h10: additional narrative, 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 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 or Problem Description
It was reported that the patient is complaining about the bhs unit and would like to switch the patient to an ortho pak.The patient stated she cannot wear the unit as the coil is falling off her foot.The patient was placing the coil underneath her sock, which was "hurting her bunion." the patient is treating the 5th met.The patient did not contact the doctor.The patient will be switched to an opak, and the bhs assembly and coils will be returned.A return label has been sent to the patient.The sflx 4 coil was not returned for evaluation.

• Brand Name: SFLX 4 COIL
• Common Device Name: BHS NON-INVASIVE STIMULATOR (COIL)
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15718033
• Report Number: 0002242816-2022-00129
• Device Sequence Number: 17417361
• Product Code: LOF
• UDI-Device Identifier: 00812301020577
• UDI-Public: 00812301020577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 1068235
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic