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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient is having an increased amount of aching and stiffness in her ankle since she started treatment with the bhs.Also, the patient was experiencing a lot of headaches, which were not normal for her.She wonders if it is related to the bone stimulator.According to her, she's been traveling recently, so the headaches may be related.As a result of the patient's aching and headaches, the sales representative asked if the doctor's office would like her to try the ortho pak.The patient agreed and said she would also consult with her doctor.The patient stated that she wore the unit for 8-10 hours at night with no medication.She is seeing a physician on thursday for a follow-up visit.She stated that the headaches could be random, but her foot was stiff and achy, and she was limping more after wearing the unit.The patient was advised to cut back to a few hours to see if that helps, and she will call back with an update.It was later reported that the doctor has requested to switch the patient to the ortho pak due to her bhs complaints.An rx was provided.An ortho pak assembly has been sent to the patient, and the bhs will be returned.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Concomitant medical product: unknown.Concomitant therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

• Brand Name: SFLX 3 COIL
• Type of Device: BHS NON-INVASIVE STIMULATOR (COIL)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13046391
• MDR Text Key: 282700644
• Report Number: 0002242816-2021-00232
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002/S026
• 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
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 1068229
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female