MAUDE Adverse Event Report: EBI, LLC. 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); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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 the patient also mentioned that she noticed a skin irritation at the 72r electrode site.She hasn't used the device since the irritation began.The patient wears the electrodes on the right shoulder.The patient has black and blue bruising on the right arm and underarm near the incision site and under her arm while she was putting on her deodorant.The patient stated that she never felt anything while using the unit.The patient¿s skin was not red or itchy and there were no welts or swelling.The patient¿s skin irritation was not strictly under the electrodes.The patient changed the electrodes every two days, and the position of the electrodes was rotated.The patient is experiencing pain below the skin and the pain is an 8 out of ten.The patient cleans the skin with soap and water.The patient does normally have sensitive skin but does not have any known allergies or seasonal allergies.The patient has not changed any product they are using topically.The patient does take blood pressure medication.The patient spoke with the surgeon and was told to continue using the device.The patient was not prescribed anything by the doctor, but they do take otc vitamin d3, vitamin c and apply cortisone to the skin.It was reported that no further information is available.

Manufacturer Narrative

The device was not 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.The following sections have been updated: h3: device evaluated by manufacturer updated to no.H6: component codes added 451-electrodes.H6: clinical codes added 4545 - skin inflammation/ irritation.H6: clinical codes added 1994 - pain.H6: clinical codes added 1754 - bruise/contusion.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.H6: investigation conclusions added 4315 - cause not established.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

The patient¿s skin was not red or itchy and there were no welts or swelling.The patient¿s skin irritation was not strictly under the electrodes.The patient changed the electrodes every two days, and the position of the electrodes was rotated.The patient is experiencing pain below the skin and the pain is an 8 out of ten.The patient cleans the skin with soap and water.The patient does normally have sensitive skin but does not have any known allergies or seasonal allergies.The patient has not changed any product they are using topically.The patient does take blood pressure medication.The patient spoke with the surgeon and was told to continue using the device.The patient was not prescribed anything by the doctor, but they do take otc vitamin d3, vitamin c and apply cortisone to the skin.It was reported that no further information is available.

• Brand Name: SOFT-TOUCH ELECTRODES, 72R
• Type of Device: 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: 13609167
• MDR Text Key: 286663165
• Report Number: 0002242816-2022-00017
• 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: 04/27/2023

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: 106130-20
• Device Lot Number: 117201
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/26/2022
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female