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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Abrasion (1689); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient complained of having a skin rash while treating with the spinal pak device at the electrode site.The patient stated that she did not know if the irritation is from the electrodes or the cover patches or both.The patient changes and rotates the electrodes and cover patches daily.She claimed that the skin irritation started about 3 months ago.The patient described the skin as red, itchy, and irritated like a burn.The patient stated that they started taking benadryl.She developed welts and water blisters.The rash spread all over even on her stomach.The first time the patient had a skin irritation, they stated that they used aloe vera leaves from the plant and the skin irritation went away.The second time the patient had a skin irritation they stated the aloe vera did not work and the skin irritation got really bad.The patient stated that she went to the er where a blood test was taken to check for an infection.The patient reported that there were no infections.The patient was given benadryl intravenous vein, and 2 other medications but did not remember the names.The patient stated that they were also given benadryl 25 mg and claritin 10 mg to take by mouth and told to go see a dermatologist.The patient then reported that they went to see their pcp doctor who prescribed betamethasone 0.1% cream.The patient stated that they stopped using the spinal pak about a month and a half ago and the patient's surgeon is aware that the patient had a skin irritation.The patient will be sending a copy of the paperwork from the er visit.The 72r electrodes lot # 200714 made in usa.Cover patches lot # 131204.The patient will wait until her skin is clear before starting the time test with the 63b electrodes.63b electrodes have been sent to the patient and the old product will be returned.No additional patient consequences have been reported.

Event Description

It was reported that the patient complained of having a skin rash while treating with the spinal pak device at the electrode site.The patient stated that she did not know if the irritation is from the electrodes or the cover patches or both.The patient changes and rotates the electrodes and cover patches daily.She claimed that the skin irritation started about 3 months ago.The patient described the skin as red, itchy, and irritated like a burn.The patient stated that they started taking benadryl.She developed welts and water blisters.The rash spread all over even on her stomach.The first time the patient had a skin irritation, they stated that they used aloe vera leaves from the plant and the skin irritation went away.The second time the patient had a skin irritation they stated the aloe vera did not work and the skin irritation got really bad.The patient stated that she went to the er where a blood test was taken to check for an infection.The patient reported that there were no infections.The patient was given benadryl intravenous vein, and 2 other medications but did not remember the names.The patient stated that they were also given benadryl 25 mg and claritin 10 mg to take by mouth and told to go see a dermatologist.The patient then reported that they went to see their pcp doctor who prescribed betamethasone 0.1% cream.The patient stated that they stopped using the spinal pak about a month and a half ago and the patient's surgeon is aware that the patient had a skin irritation.The patient will be sending a copy of the paperwork from the er visit.The 72r electrodes lot # 200714 made in usa.Cover patches lot # 131204.The patient will wait until her skin is clear before starting the time test with the 63b electrodes.63b electrodes have been sent to the patient and the old product will be returned.No additional patient consequences have been reported.The 72r electrodes were not returned for evaluation.

Manufacturer Narrative

Corrections: b4 date of this report added, b5 updated the product was not returned for evaluation, d3 manufacturer address and email address, g1 contact office, and manufacturer site, d4 unique identifier (udi) number, g6 type of report additional information: h4 device manufacture date, h6 component, investigation type, findings, and conclusions, h10 and h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to (b)(6) medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/certificate of conformance 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.(b)(6) medical will continue to monitor for trends.

• Brand Name: SOFT-TOUCH ELECTRODES, 72R
• Type of Device: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15506747
• MDR Text Key: 300880123
• Report Number: 0002242816-2022-00110
• 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
• Exemption Number: 5645646
• 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: 05/30/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 106130-20
• Device Lot Number: 200714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2022
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic