MAUDE Adverse Event Report: EBI, LLC. SFLX COILETTE

Catalog Number	1068238
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Shock (2072)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that the patient experienced an electric shock while treating with the bhs device.The customer service representative called the patient and found that last week she experienced a shock to the left foot.The level of pain could not be remembered.The patient stopped using the unit.A replacement bhs assembly and coilette were shipped to the patient's home.The patient later reported that she does not recall the pain level, only a shocking sensation.The patient stated that her doctor did not recommend any medical intervention, only to contact her sales representative to obtain a replacement device.The patient stated the old bhs assembly and coilette have been mailed back.
Event or Problem Description
It was reported that the patient experienced an electric shock while treating with the bhs device.The customer service representative called the patient and found that last week she experienced a shock to the left foot.The level of pain could not be remembered.The patient stopped using the unit.A replacement bhs assembly and coilette were shipped to the patient's home.The patient later reported that she does not recall the pain level, only a shocking sensation.The patient stated that her doctor did not recommend any medical intervention, only to contact her sales representative to obtain a replacement device.No additional patient consequences have been reported.The sflx-coilette was returned for further evaluation.
Additional Manufacturer Narrative
Investigation summary: the sflx-coilette was received for evaluation.A visual inspection of the customer returned product was performed.Included was one sflx coilette part no.1068238 with julian date 23305.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr was reviewed.All evaluation results did not show any discrepancies.The failure was not confirmed for the reported condition of "the patient experienced an electric shock while treating with the bhs".The coil was tested and operates as intended.Review of complaint history identified (2) total complaints from (mar 25, 2023) to (mar 25, 2024) for pn (1068238) and events related to (pain).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 "pain".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.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.

• Brand Name: SFLX COILETTE
• 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: 19176055
• Report Number: 0002242816-2024-00056
• Device Sequence Number: 17746236
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: Lay User/Patient
• Device Catalogue Number: 1068238
• Device Lot Number: 23305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic