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)

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

Event Type  Injury  

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

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.

Manufacturer Narrative

The device not 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: b4: date of this report added.D3: manufacturer updated.G1-2: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.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 code added to 4114- device not returned.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.

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 them 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.

• 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.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 14990644
• MDR Text Key: 295768237
• Report Number: 0002242816-2022-00065
• 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: 10/18/2022

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: 106130-20
• Device Lot Number: 109101
• 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: 09/21/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Male