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); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: (b)(6) 2022.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 patient that she is experiencing a skin irritation with the 72r electrodes.The patient claims the skin was not red, but the skin had an itchy pimply rash.The patient denies blisters, welts, or swelling.The patient claimed it was under the electrodes.The patient changed the electrodes and rotated them daily.She cleans the area with soap, water, and baking soda/water mixture.The patient denies using wipes or having sensitive skin or allergies.The patient has seasonal allergies to pine trees.She sought the advice of her ortho doctor, and he advised her to use an otc cream, which the patient did not like and she discontinued.The doctor also advised she call zimvie for a new electrode option.63b electrodes will be sent to the patient, and an example of the old electrodes will be returned.

Event Description

It was reported by the patient that she is experiencing a skin irritation with the 72r electrodes.The patient claims the skin was not red, but the skin had an itchy pimply rash.The patient denies blisters, welts, or swelling.The patient claimed it was under the electrodes.The patient changed the electrodes and rotated them daily.She cleans the area with soap, water, and baking soda/water mixture.The patient denies using wipes or having sensitive skin or allergies.The patient has seasonal allergies to pine trees.She sought the advice of her ortho doctor, and he advised her to use an otc cream, which the patient did not like and she discontinued.The doctor also advised she call zimvie for a new electrode option.63b electrodes will be sent to the patient, and an example of 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: h3: device evaluated by manufacturer updated to yes.H6: component codes added 451-electrodes.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.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: 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: 14165225
• MDR Text Key: 294638793
• Report Number: 0002242816-2022-00040
• 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: 09/21/2022

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: 123901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female