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

Catalog Number	PAD9165
Medical Device Problem Codes	Break (1069); Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there have been several instances noted of skin irritation to the patients.Also, another instance where it rips because the adhesive is too sticky.".
Additional Manufacturer Narrative
The customer reported several complaints about the grounding pad, including "skin irritant x4, attachment breaking from sticking= multiple times"; the irritation was "underneath the pad" where the adhesive was, "red and irritated," noticed "immediately" at time of removal, with no treatment required and no serious injury identified, medical intervention required, or follow-up care needed.Medline quality received 1 ea of the grounding pad 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 item has been confirmed to be at-risk for the esu plug breaking in half when the plug is removed from the grounding pad adhesive; 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: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946637
• Report Number: 1417592-2026-54308
• Device Sequence Number: 15840782
• 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): 09/29/2026

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: 03/15/2023
• 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: 03/07/2023
• Initial Report FDA Received Date: 09/30/2026
• 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