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 Bruise/Contusion (1754); Chest Pain (1776); Pain (1994); Rash (2033); Skin Tears (2516); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

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 zimviet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient called me and said she is getting irritation from the electrodes.She is requesting different electrodes that stick less.The patient stated that when she takes the 72r electrodes off some skin comes off with it and a day later she has bruising.She describes her skin as red, bruised, sore, and aggravated.The patient claims her pain is a 3 or 4 out of 10.The patient tries to rotate electrodes.She has sensitive skin, an allergy to adhesives, seasonal allergies, takes blood pressure medication, and takes blood thinners.The patient spoke with their doctor and the doctor determined that they would switch the patient to a bhs stimulator.

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 and pain.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.

Event Description

It was reported that the patient called me and said she is getting irritation from the electrodes.She is requesting different electrodes that stick less.The patient stated that when she takes the 72r electrodes off some skin comes off with it and a day later she has bruising.She describes her skin as red, bruised, sore, and aggravated.The patient claims her pain is a 3 or 4 out of 10.The patient tries to rotate electrodes.She has sensitive skin, an allergy to adhesives, seasonal allergies, takes blood pressure medication, and takes blood thinners.The patient spoke with their doctor and the doctor determined that they would switch the patient to a bhs stimulator.

• 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: 15466329
• MDR Text Key: 300398810
• Report Number: 0002242816-2022-00108
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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: 209102
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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