MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ UNIVERSAL ELECTROSURGICAL PAD; GROUNDING PAD

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Erosion (2075); Partial thickness (Second Degree) Burn (2694)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End of report.
Event or Problem Description
A hospital in (b)(6) reported a 9160f 3m¿ universal electrosurgical pad was placed on a patient's left thigh prior to a hysterectomy procedure.When the pad was removed, the patient allegedly experienced redness, blistering and skin detachment/stripping around the pad edges.The hospital reported no issue occurred under the conductive portion of the pad.The hospital reported a dermatology consult found the patient experienced 2a, 2b burns and blistering.Medical treatment was not specified.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PAD
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8400026
• Report Number: 2110898-2019-00036
• Device Sequence Number: 13550625
• Product Code: GEI
• UDI-Device Identifier: 10707387462588
• UDI-Public: 10707387462588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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 Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 9160F
• Device Lot Number: 2021 09 MG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE VIO 3 DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Weight: 70