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

Model Number N/A

Device Problem Overheating of Device (1437)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Because the lot number is unknown, the device history records could not be pulled and 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 is reported that a patient believes the coilette overheated and formed a blister on his foot.The patient reported that he went to see his doctor for the symptom.The patient advised his doctor redressed the blister and told him to apply an over the counter antibiotics.A replacement coilette was sent to the patient.The patient advised that his foot is healing and will continue to use the replacement coilette.

• Brand Name: SFLX - XL COILETTE
• Type of Device: COILETTE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 6023620
• MDR Text Key: 57194985
• Report Number: 0002242816-2016-00032
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP790002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/12/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068240
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/12/2016
• 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 Age: 43 YR