MAUDE Adverse Event Report: EBI, LLC. ELECTRODE COVER PATCHES; ELECTRODES COVER PATCHES

Model Number N/A

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

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the patient that the 72r electrodes and cover patches caused a rash on his skin.The patient wore them 24/7 and changed every other day.The patient stated experienced a rash and blistering.The patient uses the cover patches in the same spot.The patient did not speak to his doctor.He claims that he does not have sensitive skin.The patient will stop wearing the unit.Our customer service department is sending the patient the 63b electrodes.The patient will conduct the timed test and will call back if any issues.New 63b electrodes were shipped to the patient.It was further reported on (b)(6) 2021, that the patient was still getting welts.His doctor told him to stop wearing the unit and to send it back.The patient was sent a return label.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimvie for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed, and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the patient that the 72r electrodes and cover patches caused a rash on his skin.The patient wore them 24/7 and changed every other day.The patient stated experienced a rash and blistering.The patient uses the cover patches in the same spot.The patient did not speak to his doctor.He claims that he does not have sensitive skin.The patient will stop wearing the unit.Our customer service department is sending the patient the 63b electrodes.The patient will conduct the timed test and will call back if any issues.New 63b electrodes were shipped to the patient.It was further reported on september 21, 2021, that the patient was still getting welts.His doctor told him to stop wearing the unit and to send it back.The patient was sent a return label.It was reported that no further information is available.

• Brand Name: ELECTRODE COVER PATCHES
• Type of Device: ELECTRODES COVER PATCHES
• 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: 14990701
• MDR Text Key: 295765172
• Report Number: 0002242816-2022-00066
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022/S017
• 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: 05/16/2023

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: 106130-17
• Device Lot Number: 109535
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: Male