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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to zimvie 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.Zimvie will continue to monitor for trends.(b)(4) date of event: the event occurred sometime in september 2022.

Event Description

It was reported that the patient experienced pain and swelling while in treatment with the bhs device.The patient stated that the pain and swelling started thursday or friday.The patient wears the device for 10 hours.The patient rated the pain as a 7 or 8 on a scale of 1 to 10, which is considered severe.The patient wore it during the night and this morning she could barely walk.According to the patient, the pain is not on the surface of the skin.The patient reported that she has increased her daily activities.The patient spoke to the nurse and the doctor who told her to decrease the treatment.The patient stated that nothing was prescribed, but she did take ibuprofen.The patient has an appointment with the doctor.The patient was told to do the time test.She will call with an update on the time test from her doctor's appointment on thursday.No additional patient consequences have been reported.

• Brand Name: SFLX - XL COILETTE
• Type of Device: BHS NON-INVASIVE STIMULATOR (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: 15570978
• MDR Text Key: 301475198
• Report Number: 0002242816-2022-00119
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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: 1068240
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• 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