MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ELECTRODE,RADIOTRANSLUCENT,FOAM,3PK

Catalog Number	MDSM611803R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, her son had the electrodes applied for a "sleep study" and upon removing the electrodes he had "red marks that were raised, uncomfortable, and itchy".The customer reported there were "2 marks on his chest, and 2 marks on each leg".The customer reported she took him to his physician after "1 month" because the skin reaction was not improving.The customer reported the physician prescribed "0.05% betamethasone cream" and the skin reaction is now improving.Sample is not available for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, her son had the electrodes applied for a "sleep study" and upon removing the electrodes he had "red marks that were raised, uncomfortable, and itchy".

• Common Device Name: ELECTRODE,RADIOTRANSLUCENT,FOAM,3PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17501920
• Report Number: 1417592-2023-00333
• Device Sequence Number: 11361530
• Product Code: DRX
• UDI-Device Identifier: 50884389830411
• UDI-Public: 50884389830411
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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 Catalogue Number: MDSM611803R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown