MAUDE Adverse Event Report: COVIDIEN 850 RT FOAM 50/POUCH 1000/CS; ELECTRODES

Model Number 22850

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Irritation (1941); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Mw5056625.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with an electrode.The customer reports that during an mri under general anesthesia the patient received a skin irritation from the electrodes.The customer further stated that one of the electrodes was left on the patient and the patient discovered the electrode when she got home.She took off the electrode and noticed the skin reaction.The patient went back to the hospital where she was prescribed silverdine cream.The physicians diagnosis was partial thickness, burn.

Manufacturer Narrative

Submit date: 02/08/2016.A device history review could not be performed because a lot number could not be provided by the customer.There were no samples submitted with this complaint; however, the complaint will be reopened if a sample is received at a later date.Because no sample was returned with this complaint, a product examination was not possible and the reported condition could not be confirmed.Had a sample been received, it would have been evaluated against the established product requirements.Due to the nature of this type of product, it is more than likely that any skin irritation is related to skin sensitivity, and it is worth noting that patient sensitivities may have been a contributing factor.Previous complaints of this nature have not been known to cause permanent impairment or marking.This product family has been tested according to iso guidelines for biocompatibility that found both the hydrogel and skin contacting foam adhesive to be non-cytotoxic, non-irritating, and non-sensitizing.There have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients.Since this complaint is unconfirmed and no complaint trend exists and the root cause may be patient skin sensitivity, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 850 RT FOAM 50/POUCH 1000/CS
• Type of Device: ELECTRODES
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque ; CA
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5269147
• MDR Text Key: 32749441
• Report Number: 9681860-2015-00014
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22850
• Device Catalogue Number: 22850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other