MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC MRQD32415; MR CONDITIONAL CUP ELECTRODE

Model Number	MRQD32415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was on long-term electroencephalogram (eeg) monitoring.Patient initially had a cap on for eeg and the cap was replaced two days later with a new cap.This cap was not staying on and was replaced after three days and replaced with the application of 32 electrodes (on for ten days).Skin prep was applied on skin prior to glue placement of the total of 32 eeg probes placed.After removing all 32 leads, it was found that there was a skin injury below one of the 32 probes.Currently there is no pressure on the skin.The wound was covered with mepilex and the wound & ostomy care team was notified to assess the patient's skin injury.During this entire timeframe, patient's head was being offloaded with z-flo pill and the patient was on a bed with low air loss mattress with a turn and position system.Description of skin impairment: unstageable skin injury located right posterior head.Full thickness tissue loss measures 0.6cm x 0.6cm x 0.1cm.Wound base is 70% dried, adherent eschar with 30% dry, tan tissue surrounding the eschar.Injury is consistent with the shape and size of an eeg electrode.Also considered that skin injury could be from glue (super adhesive), but unsure if an adhesive injury would give a deep injury.Information received from the user facility indicated that skin prep, adhesive and conductive cream were used on the patient.

• Brand Name: MRQD32415
• Common Device Name: MR CONDITIONAL CUP ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first street south; columbia, SC 29209 ; 6783341720
• MDR Report Key: 14500455
• Report Number: 1067162-2022-00002
• Device Sequence Number: 5150944
• Product Code: GXY
• UDI-Device Identifier: 10816312023333
• UDI-Public: (01)10816312023333
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: MRQD32415
• Device Catalogue Number: MRQD32415
• Device Lot Number: PM000021427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Race: Black Or African American