MAUDE Adverse Event Report: EBI, LLC. ORTHOPAK ASSEMBLY; STIMULATOR, ORTHOPAK, 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 Problems Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that the 72r electrodes are irritating the patient's skin.The skin irritation is located on the patient's left shoulder.The physician's assistant at the doctor's office saw the patient's skin irritation and told the patient to move the electrodes.The patient places one electrode on the back and one on the front of the shoulder.The patient describes the skin as red and itchy with welts and sores.She uses the cover patches but the skin irritation is under the electrodes.The electrodes and cover patches are changed once or twice a week.The area is cleaned with soap and water.For the past 3 weeks, the patient has been using alcohol and no wipes.The patient has seasonal allergies and takes blood pressure medication and she has not used any new products.The doctor did not prescribe anything for the skin irritation.The patient was told to take allergy medication for the itching and to move the electrodes.The patient was sent replacement 63b electrodes.It was later reported on (b)(6) 2022, that the patient was told by the doctor's office to take allergy medication for the itching.No additional patient consequences have been reported.

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the 72r electrodes are irritating the patient's skin.The skin irritation is located on the patient's left shoulder.The physician's assistant at the doctor's office saw the patient's skin irritation and told the patient to move the electrodes.The patient places one electrode on the back and one on the front of the shoulder.The patient describes the skin as red and itchy with welts and sores.She uses the cover patches but the skin irritation is under the electrodes.The electrodes and cover patches are changed once or twice a week.The area is cleaned with soap and water.For the past 3 weeks, the patient has been using alcohol and no wipes.The patient has seasonal allergies and takes blood pressure medication and she has not used any new products.The doctor did not prescribe anything for the skin irritation.The patient was told to take allergy medication for the itching and to move the electrodes.The patient was sent replacement 63b electrodes.It was later reported on (b)(6) 2022, that the patient was told by the doctor's office to take allergy medication for the itching.No additional patient 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 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.D4: lot number added.D4: unique identifier (udi) number added.G1: contact office 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 4545 - skin inflammation/ irritation.H6: clinical code added 4577 - swelling/ edema.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 code 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.

• Brand Name: ORTHOPAK ASSEMBLY
• Type of Device: STIMULATOR, ORTHOPAK, NON-INVASIVE (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: 15242185
• MDR Text Key: 298067231
• Report Number: 0002242816-2022-00088
• 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: 03/23/2023

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: 123901
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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: Female