MAUDE Adverse Event Report: EBI, LLC. ORTHOPAK ASSEMBLY; STIMULATOR, ORTHO PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to zimmer biomet for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed, and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.D11: medical product: unknown d11: therapy date: unknown.

Event Description

It was reported that the patient experienced swelling with the 72r electrodes.The patient stated that within a couple of days after her surgery, while removing the electrode, a piece of skin was peeled off her foot, and within 4 days, her foot was a bit swollen.She contacted her surgeon, and she put her on antibiotics.The doctor advised her to keep the area clean with an alcohol pad to prevent infection.The patient admits her skin is very thin on her foot, and she can feel the screw from the surgery easily.She also shared that her boot also rubs on that part of her foot regularly.The patient was sent 63b electrodes.No additional patient consequences have been reported.

• Brand Name: ORTHOPAK ASSEMBLY
• Type of Device: STIMULATOR, ORTHO PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)
• 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: 14721881
• MDR Text Key: 294856047
• Report Number: 0002242816-2022-00059
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• 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: 06/16/2022

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: 1067718
• Device Lot Number: 204202
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2022
• 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