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); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2021.The device will not be 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 by the sales rep that the patient has discontinued use of her orthopak because the electrodes are causing an allergic reaction.The patient has a rash and blisters and is very itchy.She has not been able to use the bone stimulator the past two nights.She tried to move the electrodes around in the same area but the rash is expanding.The patient will call her doctor to let him know and see if he has any ideas.The patient was called regarding the skin irritation, and she stated that it started two weeks after she started treatment on the right leg.The skin is red and itchy with blisters, and it's strictly under the electrodes.The electrodes are changed about every four days.After the irritation started, the patient started moving the electrodes around.The area is cleaned with soap and water with no wipes.The patient has dermatitis and sensitive skin but no allergies.She has used no new product, but she went to the dermatologist and was prescribed hydrocortisone ointment 2.5%.The patient is not on blood pressure medication.The patient has stopped using the 72r electrodes.The patient was told to wait until her skin is clear, and then she will start the time test with 63b electrodes.63b electrodes will be sent to the patient, and the old electrodes will be returned.

Event Description

It was reported by the sales rep that the patient has discontinued use of her orthopak because the electrodes are causing an allergic reaction.The patient has a rash and blisters and is very itchy.She has not been able to use the bone stimulator the past two nights.She tried to move the electrodes around in the same area but the rash is expanding.The patient will call her doctor to let him know and see if he has any ideas.The patient was called regarding the skin irritation, and she stated that it started two weeks after she started treatment on the right leg.The skin is red and itchy with blisters, and it's strictly under the electrodes.The electrodes are changed about every four days.After the irritation started, the patient started moving the electrodes around.The area is cleaned with soap and water with no wipes.The patient has dermatitis and sensitive skin but no allergies.She has used no new product, but she went to the dermatologist and was prescribed hydrocortisone ointment 2.5%.The patient is not on blood pressure medication.The patient has stopped using the 72r electrodes.The patient was told to wait until her skin is clear, and then she will start the time test with 63b electrodes.63b electrodes will be sent to the patient, and the old electrodes will be returned.

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.D2: type of the device updated.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 updated.H2: follow up type updated.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: component codes added 451-electrodes.H6: impact code added to 4648 - insufficient information.H6: clinical code added to 4545 - skin inflammation/ irritation.H6: clinical code added to 1907 - hypersensitivity/allergic reaction.H6: clinical code added to 2033 - rash.H6: clinical code added to 4537 - blister.H6: clinical code added to1943 - itching sensation.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: d2: type of the device updated.H6: device code updated to 2993: adverse event without identified device or use problem.

• Brand Name: ORTHOPAK ASSEMBLY
• Type of Device: STIMULATOR, ORTHO PAK, 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: 12703174
• MDR Text Key: 278528215
• Report Number: 0002242816-2021-00187
• 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: 04/10/2023

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: 100101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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 Age: 21 YR
• Patient Sex: Female