MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT MACROLYTE, AD, SINGLE, CABLE DISPERSIVE ELECTRODE; ADULT GROUNDING PAD

Catalog Number 400-2100

Device Problems Human-Device Interface Problem (2949); Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Pain (1994); Scarring (2061); Post Traumatic Wound Infection (2447)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

The product is not expected to be returned, however the complaint investigation is ongoing.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Conmed received legal notification that the 400-2100, macrolyte grounding pad, was used during a abdominoplasty, liposuction and other cosmetic procedures on (b)(6) 2016.The plaintiff allegedly "suffered an opening of the surgical sutures, an extreme burn on the back of the right leg causing infections, excessive scarring, permanent disability, emotional harm, and physical pain for which plaintiff has been required to allegedly undergo additional painful surgeries, procedures, and testing.The burn on the back of the right leg occurred while under the effects of anesthesia." as of the date of this report, no medical evidence has been provided to conmed by the reporter.This report is being raised due to alleged patient injury.

Manufacturer Narrative

The device will not be returned for evaluation as it was not retained by user and no photographic evidence that exhibits the reported event has been provided.Therefore, the reported event cannot be verified.A lot history review could not be conducted as a lot number was not provided.A dhr review cannot be conducted as no lot number was provided.(b)(4).Per the instructions for use, the user is advised the following; apply the pad firmly to skin, ensuring full adhesion of the pad gel and adhesion, and full pad contact with patient's skin.Failure to achieve good skin contact by the entire adhesive surface may result in electrosurgical burns or poor electrosurgical performance.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MACROLYTE, AD, SINGLE, CABLE DISPERSIVE ELECTRODE
• Type of Device: ADULT GROUNDING PAD
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 9744272
• MDR Text Key: 192766271
• Report Number: 3007305485-2020-00080
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K120476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400-2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other