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 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

3m informed the fda that they were initiating a recall on the following products on october 25, 2016: catalog number: 9135-lp, lots 2019-02db and 2019-02cy; catalog number: 9130, lots 2019-02dt and 2019-03du.Fda has acknowledged our recall on october 26, 2016 but they have not assigned a recall number as of the date of this report.Recall letter: recall was initiated on october 26, 2016.The letter indicates the catalog numbers and lot numbers as stated above and includes the following statement: "this recall follows confirmation of a single user report of an unintended material (process liner) in the product.The presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation.This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.While there is only a remote possibility of the pads containing the process liner, 3m is requesting your prompt assistance in reviewing inventory and returning the affected lots." (b)(4).

Event Description

A male patient had a 3m(tm) universal electrosurgical pad applied to the right flank.At some point before or during endoscopic surgery, the patient was alleged to have "felt pain." the procedure was stopped.The patient was alleged to have skin redness and blister(s) under approximately 3/4th of the conductive adhesive edges of the pad.The number of blisters was not specified.The patient was alleged to also have a black line of burnt skin under the pad around the exterior edge of the conductive adhesive.Medical treatment was not specified.3m implemented a recall on selected lots and products as a result of this reported adverse reported event.The product was not returned nor examined that was applicable to the reported event.Product from the user facility with same lot and catalog number was returned and examined.

Manufacturer Narrative

Correction on age of patient.In reviewing the medwatch and complaint on 12/23/2016 it was discovered the age of the patient was incorrectly stated on the initial report.This is a follow-up report correcting the patient's age.End of report.

• 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: 6071378
• MDR Text Key: 59023272
• Report Number: 2110898-2016-00103
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

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?: Yes
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2016
• 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
• Removal/Correction Number: UNK
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR