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

Catalog Number	PAD9130
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer contact, a patient was burned by a grounding pad on (b)(6) 2023 and was given "was given otc triple antibiotic ointment day of procedure to take home and apply to the affected area.Physician called in clindamycin 300mg q 8 hours for 7 days".It was reported, that on (b)(6) 2023 "patient was seen in clinic as follow up-patient has skin burn degree 1( 3 cm by 3 cm) over right lateral abdominal area at the site of grounding patch that has improved a lot in the last two days.Patient does use dressing.Ointment including vaseline as needed and reports that it has gotten much better.No drainage, no open wound, slight erythema, small 1cm x 1 cm serous blister present on the front edge." a sample was 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.
Event or Problem Description
Patient burn.

• Common Device Name: PAD, GROUNDING, UNIVERS, SOLID, UNCO
• 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: 17556749
• Report Number: 1417592-2023-00343
• Device Sequence Number: 3584035
• Product Code: GEI
• UDI-Device Identifier: 10193489082487
• UDI-Public: 10193489082487
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/16/2023

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 Catalogue Number: PAD9130
• Device Lot Number: (10)27122120008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/16/2023
• 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