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

Model Number	PAD9135-LP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 during an or procedure in which cautery was being used, the patient experienced a burn on their "left anterior thigh that reached the subcutaneous tissue and required wound debridement and sutures for primary closure".Per the facility the patient's skin was intact prior to the procedure and there was no metal located on that portion of the patient's body.Per the facility there were "three areas on the grounding bad that reflected the area that was burned on the patient".Per the facility the patient has no known allergies and no known dermatological issues that would contribute to the reported issue.Sample requested to be returned for evaluation.No additional information is available 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 facility on (b)(6) 2023 during an or procedure in which cautery was being used, the patient experienced a burn on their "left anterior thigh that reached the subcutaneous tissue and required wound debridement and sutures for primary closure".

• Brand Name: Medline
• Common Device Name: PAD, GROUNDING, UNIVERSAL, SOLID, 9'
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17321410
• Report Number: 1417592-2023-00293
• Device Sequence Number: 17865991
• Product Code: GEI
• UDI-Device Identifier: 10193489082500
• UDI-Public: 10193489082500
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/13/2023

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 Model Number: PAD9135-LP
• Device Catalogue Number: PAD9135-LP
• Device Lot Number: 27122090003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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