MAUDE Adverse Event Report: EBI, LLC. SFLX 3 COIL

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient stated he has a burning sensation, and he only used the unit for a couple of weeks.The patient stated he wore the unit for 1 week.He wore the unit for 10 hours.Once he started treatment, he would feel a numbing tingling sensation similar to your foot falling asleep, followed with burning under the skin.He wore a sock so it was not on top of the skin.He also stated that he did not know how much the unit would cost.The patient had an appointment on monday (b)(6) 2022, where the doctor told him not to wear the unit anymore.The bhs unit will be returned.
Additional Manufacturer Narrative
Zimvie complaint# (b)(4).Date of event: (b)(6) 2022.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.
Additional Manufacturer Narrative
Investigation summary: the sflx 2 coil was received for evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 2 coil part no.1068226 with (b)(6) date 21062.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 2 coil was reviewed in the product information section and there were no reports of non-conformances or deviations.The failure was not confirmed for the reported condition of "burning sensation from bhs".The coil was tested and operates as intended.Review of complaint history identified (1) total complaints from (feb 4, 2021) to (feb 1, 2022) for pn (1068226) and events related to (burn).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "burn".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.Highridge medical will continue to monitor for trend.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported by the patient advocacy department that the patient stated he has a burning sensation, and he only used the unit for a couple of weeks.The patient stated he wore the unit for 1 week.He wore the unit for 10 hours.Once he started treatment, he would feel a numbing tingling sensation similar to your foot falling asleep, followed with burning under the skin.He wore a sock so it was not on top of the skin.He also stated that he did not know how much the unit would cost.The patient¿s physician advised to stop wearing the unit.No additional patient consequences have been reported.The sflxcoil was returned for further evaluation.

• Brand Name: SFLX 3 COIL
• Common Device Name: 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13664558
• Report Number: 0002242816-2022-00025
• Device Sequence Number: 4756258
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/27/2024

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: 1068226
• Device Lot Number: 21062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic