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

Catalog Number 9165

Device Problem Human-Device Interface Problem (2949)

Patient Problems Erythema (1840); Itching Sensation (1943); Partial thickness (Second Degree) Burn (2694); Blister (4537); Swelling/ Edema (4577)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

A1 & a4-a6: not provided.B3: date of event: not provided.E1: reporter name & address: not provided.E2 -e3: it is unknown if the reporter is a health professional.H10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states, to reduce the risk of burns the site must be clean, dry and free of hair and to remove hair at application site.3m¿ will continue to monitor.

Event Description

A 78-year-old female allegedly experienced an anterior thigh second-degree burn with 13 cm localized redness, swelling, itching sensation, maceration, pain, blistering, and permanent damage five hours post application of 3m¿ universal electrosurgical pads, 9165 lot 202509md.The patient underwent a 5-hour hysterectomy procedure and has no known history of sensitivity or allergic reaction to skin, medications, or food.The scalpel was reportedly installed by the surgeon, and was up to date with preventive maintenance, bipolar mode, with no findings of nonconformities.The hospital confirmed no additional information or photos will not be provided.

• Brand Name: 3M¿ UNIVERSAL ELECTROSURGICAL PADS
• Type of Device: GROUNDING PAD
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17653680
• MDR Text Key: 322322014
• Report Number: 2110898-2023-00077
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 50707387523973
• UDI-Public: 50707387523973
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K974279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2023

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 Operator: Health Professional
• Device Catalogue Number: 9165
• Device Lot Number: 202509MD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female