MAUDE Adverse Event Report: 3M HEALTH CARE 3M(TM) UNIVERSAL ELECTROSRUGICAL PAD; DISPERSIVE ELECTRODE

Model Number N/A

Device Problem Failure to Obtain Sample (2533)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 10/25/2016

Event Type  No Answer Provided  

Manufacturer Narrative

See 2110898-2016-00103 for more information related a recall that includes this lot and catalog number.This adverese report was subsequent to the recall action and product was used and not retained by the user.End of report.

Event Description

A male patient had a 3m(tm) universal electrosurgical pad applied prior to an unspecified surgery.When the pad was removed, the hospital staff noticed a small area of redness which was alleged to be a burn.The severity of the alleged burn was mild.Medical treatment was not specified.3m implemented a recall on selected lots and products as a result of a previous reported adverse event involving same product and lot number.Customer reported this adverse event as a result of our recall.The hospital had not reported the event because the severity was mild (small redness) but due to the recall they reported this event since it included the same lot number and catalog number that was part of the recall.Product used was not returned to 3m.The process liner over the conductive adhesive was noted as random within the lot used and applicable to this report.Without the product it is not possible to confirm product did or did not contain the process liner.

• Brand Name: 3M(TM) UNIVERSAL ELECTROSRUGICAL PAD
• Type of Device: DISPERSIVE ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 6070707
• MDR Text Key: 58917253
• Report Number: 2110898-2016-00102
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 9135-LP
• Device Lot Number: 2019-02 DB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2016
• 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: 74 YR