MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES AND COVER PATCHES)

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 bad rash.She wore them for 24 hours and changed them every 2-3 days.She had blisters on her neck.A nurse has told the patient to use hydrocortisone.The patient has sensitive skin.She is allergic to band-aids and paper tape.

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 by the patient that the 72r electrodes and cover patches caused a bad rash.She wore them for 24 hours and changed them every 2-3 days.She had blisters on her neck.A nurse has told the patient to use hydrocortisone.The patient has sensitive skin.She is allergic to band-aids and paper tape.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device 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.Zimmer biomet will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D3: manufacturer lot#.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 yes.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 findings code added to 3221: no findings available.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES AND COVER PATCHES)
• 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: 13547065
• MDR Text Key: 285812073
• Report Number: 0002242816-2022-00015
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• 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: 09/09/2022

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: 1067716
• Device Lot Number: 117201/122119
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• 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