MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 72R; SOFT TOUCH ELECTRODES

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Irritation (1941); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.Concomitant medical products: medical prescription: carbediol 25mg twice a day and thyroid medication.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 that the patient had an internal sciatic stimulator for pain in the left side buttocks.The patient called and stated that she has an allergic reaction from the 72r electrodes on the lumbar area.The skin is red and itchy.Changing and rotating the electrodes every 8 to 12 hours, the irritation is right under the electrodes.The patient starts getting itchy after one hour.

Event Description

It was reported that the patient had an internal sciatic stimulator for pain in the left side buttocks.The patient called and stated that she has an allergic reaction from the 72r electrodes on the lumbar area.The skin is red and itchy.Changing and rotating the electrodes every 8 to 12 hours, the irritation is right under the electrodes.The patient starts getting itchy after one hour.

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.

• Brand Name: SOFT-TOUCH ELECTRODES, 72R
• Type of Device: SOFT TOUCH ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 11272395
• MDR Text Key: 230043749
• Report Number: 0002242816-2021-00011
• 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/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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 106130-20
• Device Lot Number: 017801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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 Sex: Female