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

Model Number N/A

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient's skin has irritation on the left foot.The skin irritation started about a week and half ago.The patient is using the 72r electrodes.The skin is very red with blisters.It is strictly under the electrodes.The electrodes are changed every 2 days, and the electrodes are not rotated.The area is clean with soap and water.The patient did not use wipes.The patient does not have sensitive skin.The patient has not used any new product; detergents, soaps or lotions on his skin.He des not have any allergies.The patient takes blood pressure medication.The patient went to see his doctor who told him to stop using the bone growth stimulator.The patient was sent replacement 63b electrodes.It was reported that no further information is available.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.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.The following sections have been updated: b4: date of this report added.G1-2: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: investigation code added 3331 - analysis of production records.H6: investigation code added 4114- device not returned.H6: investigation findings code added to 3221: no findings available.H10: additional narratives/data.The following sections have been corrected: e3: occupation updated to non-healthcare professional.H6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported by the sales rep that the patient's skin has irritation on the left foot.The skin irritation started about a week and half ago.The patient is using the 72r electrodes.The skin is very red with blisters.It is strictly under the electrodes.The electrodes are changed every 2 days, and the electrodes are not rotated.The area is clean with soap and water.No wipes.The patient does not have sensitive skin.No new product.No allergies.The patient takes blood pressure medication.The patient went to see his doctor who told him to stop using the bone growth stimulator.No prescription.72r electrodes lot # 115901.63b electrodes and usps pouch was shipped to the patient.A return pouch has been sent to the patient.

• Brand Name: ORTHOPAK ASSEMBLY
• Type of Device: STIMULATOR, ORTHO PAK, NON-INVASIVE (72R ELECTRODES)
• 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: 13367880
• MDR Text Key: 285648633
• Report Number: 0002242816-2022-00005
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• 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,Followup
• Report Date: 05/13/2022

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: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male