MAUDE Adverse Event Report: EBI, LLC. SFLX - COILETTE

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that she had pain and discomfort from the bhs unit.The patient used the device 10 hours at night while sleeping.During the day she felt discomfort in her first and second toe that was not constant but was at times a 7 out of 10.The patient claims this felt like pain and nerves.The patient stated that when she bent her toes the pain was a 5 out of 10.This pain was below the surface of the skin.The patient claims she has not increased her physical activities.The patient claims she has not spoken to any medical professional about this pain.But the sales representative has reached out to the doctor for his opinion and will update us as soon as they hear back from the doctor.It was later reported by the patient that the sales representative reached out to her doctor regarding the pain.The patient stated that the doctor told the representative to switch the patient to an orthopak device due to the pain.The patient also stated that she was using the sflx coilette to treat.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (b)(6) 2023.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
Investigation summary: the sflx coilette was returned for further evaluation.A visual inspection of the customer returned product was performed.Included was one sflx coilette part no.1068238 with (b)(6) date 22322.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx coilette was reviewed in the product information section and there were no reports of non-conformances or deviations.The sflx coilette was tested, and it operates as intended.The failure was not confirmed for the reported condition of "medical--pain".The coil was tested and operates as intended.Review of complaint history identified (2) total complaints from (jun 6, 2022) to (jun 6, 2023) 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.
Event or Problem Description
It was reported by the patient that she had pain and discomfort from the bhs unit.The patient used the device 10 hours at night while sleeping.During the day she felt discomfort in her first and second toe that was not constant but was at times a 7 out of 10.The patient claims this felt like pain and nerves.The patient stated that f she bent her toes the pain was a 5 out of 10.This pain was below the surface of the skin.The patient claims she has not increased physical activities.Patient claims she has not spoken to any medical professional about this pain.But the sales rep has reached out to the doctor for his opinion and will update us as soon as they hear back from the doctor.Further, it was reported by the patient that the sales rep reached out to her doctor regarding the pain.The patient stated that the doctor told the sales rep to switch the patient to an orthopak due to the pain.No additional patient consequences have been reported.The sflx coilette was returned for further evaluation.

• 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: 17102134
• Report Number: 0002242816-2023-00074
• Device Sequence Number: 11239666
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 1068238
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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
• 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: 23 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic