MAUDE Adverse Event Report: EBI, LLC. SFLX 3 COIL; NON-INVASIVE, SFLX 3 COIL

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2020.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 or Problem Description
It was reported by the sales rep that the patient reports that she feels spasms in her foot about 30-45 minutes after use.She did advise when she feels this, she takes the device off and it stops, then continues treatment.The patient stated that the spasms started the first time she used the bhs and within 15 minutes the patient stated that she had pain and the foot jumped.It is like a throbbing aching pain.The pain diminishes after 6 hours of using the stimulator.The pain level is 8 to 9.The pain is below the skin deep inside.The patient does not have pain when she is not treating.The patient has increased her daily activity but now she has slowed down.The patient did speak to her physician.The doctor told her that it was probably because she was on her feet too long.The patient stated that it is a different pain when she is on her feet then when she is using the stimulator.The doctor prescribed antibiotics and percocet.I told the patient to do the time test.Increase every day by an hour and to keeps us posted on the progress.The patient wears the coil over a sock and ace bandage.
Additional 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 pain.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.
Event or Problem Description
It was reported by the sales rep that the patient reports that she feels spasms in her foot about 30-45 minutes after use.She did advise when she feels this, she takes the device off and it stops, then continues treatment.The patient stated that the spasms started the first time she used the bhs and within 15 minutes the patient stated that she had pain and the foot jumped.It is like a throbbing aching pain.The pain diminishes after 6 hours of using the stimulator.The pain level is 8 to 9.The pain is below the skin deep inside.The patient does not have pain when she is not treating.The patient has increased her daily activity but now she has slowed down.The patient did speak to her physician.The doctor told her that it was probably because she was on her feet too long.The patient stated that it is a different pain when she is on her feet then when she is using the stimulator.The doctor prescribed antibiotics and percocet.I told the patient to do the time test.Increase every day by an hour and to keeps us posted on the progress.The patient wears the coil over a sock and ace bandage.

• Brand Name: SFLX 3 COIL
• Common Device Name: NON-INVASIVE, SFLX 3 COIL
• 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: 11177840
• Report Number: 0002242816-2021-00006
• Device Sequence Number: 3920123
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068229
• 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: 12/18/2020
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female