MAUDE Adverse Event Report: EBI, LLC. SFLX 4 COIL

Catalog Number	1068235
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Paresthesia (4421); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is having trouble with her bhs device.The patient stated that she feels the top of her toes stings.The patient described it as a burning sensation which hurts really bad after using the device.The patient saw her doctor yesterday.The patient's foot is very swollen because of the surgery.The foot is really sensitive.She had the surgery 9 days ago.The patient is using sflx 4 coil.The patient stated that her splint had been replaced and was not as bulky.The coil 4 is now a little bit too big.A new slfx 4 coil sent to the patient.The patient later reported that the pain is like a burning sensation in her nerves and that she believes the bhs is increasing her pain.The patient spoke to her doctor and was told to call (b)(6).The doctor also prescribed gabapentin for nerve pain.The patient also stated that the pain was an 8 or 9 when stationery and was a ten out of ten when she is moving around.The patient is not treating with the unit at this time and her doctor has been made aware of this.The patient decided to stop treatment on her own due to the pain.She will resume treating when she receives the new coil.No further consequences have been reported at this time.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported by the sales representative that the patient is having trouble with her bhs unit.The patient was called to troubleshoot the unit.The patient stated that she feels the top of her toes stings and feels like a burning sensation which hurts bad after using the unit.The patient saw her doctor yesterday.The patient's foot is very swollen because of the surgery.The foot is sensitive.She had the surgery 9 days ago.The patient is using sflx 4 coil.The patient stated that her splint was changed, and it is not as bulky.The coil 4 is now a little bit too big.Later, the patient stated that the pain is like a burning sensation in her nerves and that she believes the bhs is increasing her pain.The patient spoke to her doctor and was told to call zimvie.The doctor also prescribed gabapentin for nerve pain.The patient also stated that the pain was an 8 or 9 when stationery and was a ten out of ten when she is moving around.The patient is not treating with the unit at this time and her doctor has been made aware of this.The patient decided to stop treatment on her own due to the pain.She will resume treating when she receives the new coil.No additional patient consequences have been reported.The sflx-4 coil was returned for further evaluation.
Additional Manufacturer Narrative
Investigation summary: the sflx 4 coil was returned for further evaluation.A visual inspection of the customer returned product was performed.Included was one sflx 4 coil part no.1068235 with julian date 22293.The part appeared to be in good condition from the cosmetic/visual point of view.The failure was not confirmed for the reported condition of "burning sensation from bhs unit and coil".The coil was tested and operates as intended.Review of complaint history identified (1) total complaints from (nov 29, 2022) to (nov 29, 2023) for pn (1068235) 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 4 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 18291615
• Report Number: 0002242816-2023-00136
• Device Sequence Number: 6667631
• Product Code: LOF
• UDI-Device Identifier: 00812301020577
• UDI-Public: 00812301020577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/24/2024

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: 1068235
• Device Lot Number: 22293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic