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

Model Number	PAD9135-LP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Burn requiring treatment.
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 a patient underwent a procedure in which a grounding pad was placed on left thigh.There were no complications reported regarding the grounding pad after the procedure, however on (b)(6) 2023 the patient reported back to the facility with "burns on left posterior thigh".She was prescribed silvadene cream, an antibiotic and referred to a plastic surgeon.The customer contact reports the patient noticed the burns the day of surgery.The sample has been requested to be returned for evaluation.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.

• 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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16852980
• Report Number: 1417592-2023-00195
• Device Sequence Number: 6565008
• Product Code: GEI
• UDI-Device Identifier: 10193489082500
• UDI-Public: 10193489082500
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/02/2023

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-LPH
• Device Lot Number: 27122070004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/02/2023
• 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