MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDGEL; ELECTRODE, FOAM, 50PK

Catalog Number	MDSM611550
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer phone call, she had gone to the hospital on (b)(6) 2025 and they placed medline electrodes on her.That caused a skin reaction, burning, and itching to the skin.Because of the skin reaction, she went to see a dermatologist and was prescribed steroid creams.She is also using no additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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 phone call, she had gone to the hospital on (b)(6) 2025 and they placed medline electrodes on her.That caused a skin reaction, burning, and itching to the skin.
Additional Manufacturer Narrative
Updated d2a: common device name.Updated d4: catalog number.Updated d4: lot number.Updated d4:expiration date.Updated d4: primary unique identifier (udi) #.Updated h4: device manufacturing date.

• Brand Name: MEDGEL
• Common Device Name: ELECTRODE, FOAM, 50PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753 ; 2173279112
• MDR Report Key: 24506790
• Report Number: 1417592-2026-00181
• Device Sequence Number: 9943575
• Product Code: DRX
• UDI-Device Identifier: 20884389830342
• UDI-Public: 20884389830342
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/16/2026

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: MDSM611550
• Device Lot Number: 65925060070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2025
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 64 KG