MAUDE Adverse Event Report: EBI, LLC. SFLX COILETTE

Catalog Number	1068238
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient mentioned that her foot has started to hurt where she has the bhs.The patient said the word throbbing but then also said she couldn't explain the feeling.The patient was called and described the feeling as a pulling/burning sensation.The patient stated that the pain started a couple of days ago.The patient stated that the pain is only while she is using the device.The patient stated that it is like a burning sensation/pressure.The patient does not feel anything when she is not using the device.The patient has increased her daily activity lately.The patient stated that the pain level is 8 when she is not taking pain medication.The patient is taking oxycodone 10/325.The patient is going back to the doctor on the 22nd.The patient is using the device about 5 hours because of the burning and aching.No additional information has been received 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 the patient mentioned that her foot has started to hurt where she has the bhs.The patient said the word throbbing but then also said she couldn't explain the feeling.The patient was called and described the feeling as a pulling/burning sensation.The patient stated that the pain started a couple of days ago.The patient stated that the pain is only while she is using the device.The patient stated that it is like a burning sensation/pressure.The patient does not feel anything when she is not using the device.The patient has increased her daily activity lately.The patient stated that the pain level is 8 when she is not taking pain medication.The patient is taking oxycodone 10/325.The patient is going back to the doctor on the 22nd.The patient is using the device about 5 hours because of the burning and aching.No additional information has been received at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was unable to be reviewed as the lot number is unknown.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.Highridge medical will continue to monitor for trends.

• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19091190
• Report Number: 0002242816-2024-00044
• Device Sequence Number: 7558628
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/18/2024

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
• Was Device Available for Evaluation?: No
• 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: 04/11/2024
• Supplement Report FDA Received Date: 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic