MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; BHS NON-INVASIVE STIMULATOR

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.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.

Event Description

It was reported that the experienced pain wile treating with the bone healing system.The patient pulled the velcro on her sflx 2 coil so tight that the coil burned her foot.The patient then took a 3-4 hour break from treatment, and then tried to treat again and pulled the coil very tight, but the coil started to heat up after 15 minutes so she stopped and called customer service.The patient was advised that she should never pull the velcro on the coil too tight.The velcro should only be tight enough so that it doesn't fall off her foot.The sales representative was called, and he suggested that she wear a sock under the coil.If there's an issue with it falling off in bed, she can loosely wrap an ace bandage over the coil so it doesn't fall off her foot during the night.The suggestion was discussed with the patient, but she said she does not plan to treat in bed at this time.The patient claims she will pause treatment at night and try to treat tomorrow while adhering to suggestions.It was later reported that the patient's pain was on her skin.The patient rated her pain as a 10 on a scale of 1 to 10, which is considered severe.The patient has not increased their daily activities.The patient has not contacted the doctor, but will be doing so.The patient did not take any over the counter medication for the pain.The patient stated that she wraps her foot in an ace bandage and then puts on the coil and the pain has gone away.No additional patient consequences have been reported.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: BHS NON-INVASIVE STIMULATOR
• 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: 12964301
• MDR Text Key: 283309066
• Report Number: 0002242816-2021-00221
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 1068234
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• 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