MAUDE Adverse Event Report: EBI, LLC SFLX - COILETTE

Catalog Number 1068238

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Type  Injury  

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 Description

It was reported the patient experienced pain and rising blood pressure while using the bhs device.This patient was switched from a bone healing assembly to an orthopak assembly.No additional patient consequences have been reported.

• Brand Name: SFLX - COILETTE
• Type of Device: 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: 17599941
• MDR Text Key: 321711034
• Report Number: 0002242816-2023-00092
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1068238
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic