MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAD, GROUNDING, UNIVERSAL, SPLIT, 9'

Catalog Number	PAD9165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "skin irritant x4, attachment breaking from sticking= multiple times.".
Additional Manufacturer Narrative
The customer reported "skin irritant x4, attachment breaking from sticking= multiple times," with irritation "where the adhesive was," noticed "immediately" at time of removal, and the skin looked "red and irritated"; treatment was "none" and no serious injury, medical intervention, or follow-up care was reported as "none that i know of, resolved over time." medline quality received 1 ea of pad9165 for evaluation, and physical inspection was conducted with the provided sample.The customer did not provide any evidence of skin irritation caused by the grounding pad and at this time this issue cannot be confirmed; at the same time the issue with the plug has been confirmed, as the plug was damaged.The suspected root cause is a manufacturing issue, and the division will continue to monitor the issue for trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: PAD, GROUNDING, UNIVERSAL, SPLIT, 9'
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866510
• Report Number: 1417592-2026-48476
• Device Sequence Number: 10715068
• Product Code: GEI
• UDI-Device Identifier: 20193489082538
• UDI-Public: 20193489082538
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PAD9165
• Device Lot Number: (10):2712209000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown