MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; PAD, GROUNDING, UNIVERS, SOLID, UNCO

Model Number	PAD9130
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the grounding pad caused "2 moon shape burns on posterior thigh" after "10 min" of application.The customer reported a new pad was applied and the burn was treated with "silvadene and an abdominal pad".The customer reported the procedure was able to be completed and the burn is currently "healing".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, 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, the grounding pad caused "2 moon shape burns on posterior thigh" after "10 min" of application.

• Brand Name: Medline
• Common Device Name: PAD, GROUNDING, UNIVERS, SOLID, UNCO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16973989
• Report Number: 1417592-2023-00226
• Device Sequence Number: 14066835
• Product Code: GEI
• UDI-Device Identifier: 10193489082487
• UDI-Public: 10193489082487
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: PAD9130
• Device Catalogue Number: PAD9130
• Device Lot Number: (10)27122110005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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