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

Model Number PAD9135-LP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 06/22/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 319022128
• Report Number: 1417592-2023-00293
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10193489082500
• UDI-Public: 10193489082500
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other