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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported by the patient that the unit is hurting her really bad.The patient stated that her foot starts hurting after about 3-4 hours of use.She stated that she puts on a sock, waits a half hour, and then within an hour it starts hurting, throbbing, and feeling hot.The patient stated that the foot looks red and swollen.The patient did not seek medical treatment.The patient rated the pain as 10 on a scale of 1 to 10, with 10 being the highest.It was later reported by the patient on (b)(6) 2022, that it is very painful and that the pain is right on the break of the toe.The patient also reported that she feels a tingling sensation as soon as she puts the coil on.The patient stated that the pain goes away immediately when she takes off the coil.The patient reported that she has not spoken to her doctor regarding the pain and is still treating with the product.The patient was advised to contact her doctor if the pain does not stop.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.The device has not been 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.

• Brand Name: SFLX - XL COILETTE
• Type of Device: COIL
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 14990630
• MDR Text Key: 295769877
• Report Number: 0002242816-2022-00069
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002/S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068240
• Device Lot Number: 22053
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female