MAUDE Adverse Event Report: EBI, LLC. SFLX 2 COIL

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain and/ or cramping while using the bhs device (coil).The customer service representative called the patient to collect additional details but had to leave a voicemail.No replacements items noted.It was reported by the patient that the cramping happens right after he finishes treating for about 2 hours.It is like a charley horse.The patient feels like a muscle spasm below the skin.The patient stated that he feels a little twinge while wearing the unit.The patient stated that the pain level is a 9 and it wakes him up.The pain starts in about 10 to 20 minutes after he finishes treating.The patient has not increased his daily activity.The patient is in a wheelchair.The patient spoke to his doctor and was told to just take tylenol.The doctor told the patient to stop using the bhs.The patient also stated that the pigtail is coming off the device.The customer service representative spoke with the patient about the orthopak and the patient said if his doctor approves the switch he will try it.Customer service representative contacted the sales representative to make them aware of the conversation with the patient.No additional information has been received by the patient.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (b)(6) 2023.D11: medical product: unknown.D11: 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.
Additional Manufacturer Narrative
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/certificate of conformance 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 experienced pain and/or cramping while using the bhs device.The customer service representative called the patient to collect additional details but had to leave a voicemail.No replacements items noted.It was reported by the patient that the cramping happens right after he finishes treating for about 2 hours.It is like a charley horse.The patient feels like a muscle spasm below the skin.The patient stated that he feels a little twinge while wearing the unit.The patient stated that the pain level is a 9 and it wakes him up.The pain starts in about 10 to 20 minutes after he finishes treating.The patient has not increased his daily activity.The patient is in a wheelchair.The patient spoke to his doctor and was told to just take tylenol.The doctor told the patient to stop using the bhs.The patient also stated that the pigtail is coming off the device.The customer service representative spoke with the patient about the orthopak and the patient said if his doctor approves the switch he will try it.Customer service representative contacted the sales representative to make them aware of the conversation with the patient.No additional information has been received by the patient.The coil was not returned for evaluation.

• Brand Name: SFLX 2 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: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17004636
• Report Number: 0002242816-2023-00066
• Device Sequence Number: 7150796
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 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: 05/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/14/2024
• 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 Age: 66 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic