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

Catalog Number	PAD9135-LP
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that generators not recognizing pads, customer has tried troubleshooting by connecting the same pads to multiple generators.
Additional Manufacturer Narrative
The account reported finding generators not recognizing pads, and the customer has tried troubleshooting by connecting the same pads to multiple generators.Functional inspection was conducted with the provided sample, no issues have been found; 2 ea were received for investigation, the received items were used, one of the pads was folded in half, the other one was sticked to the packaging, the gel on the pad was also in bad condition, and both items were working properly when connected to the generator.Based on the complaint details, sample evaluation and investigation, the complaint cannot be confirmed.The vendor was notified and the dhr was reviewed; the production process was not the reason for this product quality complaint issue, there was no change in production process, and the review did not indicate any potential causes of the defect.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, SOLID, 9'
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50669403
• Report Number: 1417592-2026-33710
• Device Sequence Number: 21139191
• Product Code: GEI
• UDI-Device Identifier: 10193489082500
• UDI-Public: 10193489082500
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/03/2026

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: PAD9135-LP
• Device Lot Number: 27124120005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2025
• 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: 05/09/2025
• Initial Report FDA Received Date: 09/08/2026
• 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