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

Model Number N/A

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

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in july 2022.Medical product: unknown.Therapy date: unknown.Device evaluation anticipated.The product has been returned and is pending evaluation for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient is having skin issues while treating with the orthopak device.The patient state that it happened about a week ago on the right side of the right foot by the metatarsal.She does not know if it is from the electrodes.The patient described the skin as red and burning.There are no welts nor blisters.The skin is kind of peeling off.The electrodes and cover patches are being changed every day.However, the patient keeps them in the same area.The area is cleaned with soap and water.The patient does not have sensitive skin, has no seasonal allergies, nor is she on blood pressure medication.The patient is allergic to bees.She uses a mild lotion on the skin.The patient that it felt like alligator skin.The patient also has pain internally.It hurts mostly half an hour after she puts the stimulator on for treatment, during the 12 hours of treatment, and half an hour after treatment finishes.The pain level is a 3 or a 4.The patient has not increased her daily activity.The patient did not speak to the doctor.She was sent replacement 63b electrodes were sent to the patient it was later reported by the patient who stated that she did not have a rash.She had a burning under the skin near the metal plate with a lot of screws.The patient does not believe it's the orthopak device.She believes is the internal instrumentation causing the issue.The patient stated that the doctor is aware of the pain/burning sensation but he did not know what it was.The patient only feels discomfort when she uses the device.The patient is happy because the bone is healing.The patient is still using the stimulator.The patient is also moving the electrodes around.The patient is very happy with the experience with zimvie and all the follow-ups.The patient later stated that her skin is much better since using the 63b electrodes.She has sent 1 pack of the 722r electrodes back.She did not see her doctor, however, she has an appointment and will call us back.It was later reported stated doctor did not prescribe anything for the pain.The patient rated the pain level a 6 out of 10.The patient stated that she was given clotrimazole cream and betamethasone so she did not get a fungal infection.The patient stated again that the skin irritation was not causing the pain.And that it was bearable.No further consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with burning sensation and 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 zimvie will continue to monitor for trends.The following sections have been updated: b4: date of this report added d3: manufacturer updated g3: date received by manufacturer added g6: type of report h2: follow up type h3: device evaluated by manufacturer updated to yes h4: device manufacturer date added h6: component codes added 451-electrodes h6: impact code added 4648 - insufficient information h6: clinical code added 2146 - burning sensation.H6: clinical code added 4545 - skin inflammation/ irritation h6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records h6: investigation code added to 4119 ¿ insufficient information available h6: investigation findings code added to 3221: no findings available h6: investigation conclusions added to 4315 - cause not established h10: additional narratives/data the following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported that the patient is having skin issues while treating with the orthopak device.The patient state that it happened about a week ago on the right side of the right foot by the metatarsal.She does not know if it is from the electrodes.The patient described the skin as red and burning.There are no welts nor blisters.The skin is kind of peeling off.The electrodes and cover patches are being changed every day.However, the patient keeps them in the same area.The area is cleaned with soap and water.The patient does not have sensitive skin, has no seasonal allergies, nor is she on blood pressure medication.The patient is allergic to bees.She uses a mild lotion on the skin.The patient that it felt like alligator skin.The patient also has pain internally.It hurts mostly half an hour after she puts the stimulator on for treatment, during the 12 hours of treatment, and half an hour after treatment finishes.The pain level is a 3 or a 4.The patient has not increased her daily activity.The patient did not speak to the doctor.She was sent replacement 63b electrodes were sent to the patient it was later reported by the patient who stated that she did not have a rash.She had a burning under the skin near the metal plate with a lot of screws.The patient does not believe it's the orthopak device.She believes is the internal instrumentation causing the issue.The patient stated that the doctor is aware of the pain/burning sensation but he did not know what it was.The patient only feels discomfort when she uses the device.The patient is happy because the bone is healing.The patient is still using the stimulator.The patient is also moving the electrodes around.The patient is very happy with the experience with zimvie and all the follow-ups.The patient later stated that her skin is much better since using the 63b electrodes.She has sent 1 pack of the 722r electrodes back.She did not see her doctor, however, she has an appointment and will call us back.It was later reported stated doctor did not prescribe anything for the pain.The patient rated the pain level a 6 out of 10.The patient stated that she was given clotrimazole cream and betamethasone so she did not get a fungal infection.The patient stated again that the skin irritation was not causing the pain.And that it was bearable.No further consequences have been reported.

• Brand Name: ORTHOPAK ASSEMBLY
• Type of Device: ORTHO PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15524855
• MDR Text Key: 301009663
• Report Number: 0002242816-2022-00112
• 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,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• 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: 207001
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female