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 Rash (2033); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: the event occurred sometime in august 2021.Medical product: unknown therapy date: unknown 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 that the patient stated that the electrode covers were causing a rash.The patient was instructed by his doctor to remove the cover patches and apply a cream.The patient was using benadryl cream.The patient's doctor stated to leave off electrodes until the skin was completely cleared.Afterwards, he could try to resume with new electrodes.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 zimmer biomet 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 that the patient stated that the electrode covers were causing a rash.The patient was instructed by his doctor to remove the cover patches and apply a cream.The patient was using benadryl cream.The patient's doctor stated to leave off electrodes until the skin was completely cleared.Afterwards, he could try to resume with new electrodes.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.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12416295
• MDR Text Key: 272670095
• Report Number: 0002242816-2021-00158
• 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: 03/28/2022

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: 106130-17
• Device Lot Number: 109535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 03/29/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male