MAUDE Adverse Event Report: COVIDIEN 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31.1925.21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that over the weekend there was an incident of burns on a patient following the use of ecg electrodes.Additional information stated that the burns have evolved favorably with the use of flammazine, antibacterial ointment.The patient is a 80+ year old female.

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. in addition to photos, five representative electrodes were returned to the manufacturing site for the investigation.The samples that arrived were used (already applied to a patient) and contaminated.Devices returned in this condition cannot be used for any type of analysis.As a result, a proper root cause analysis could not be performed.In general, skin irritations may be caused by an allergic reaction against one of more components of the electrode, pre-treated skin, or patient medication.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• MDR Report Key: 10721817
• MDR Text Key: 212587131
• Report Number: 9710060-2020-00205
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 31.1925.21
• Device Catalogue Number: 31.1925.21
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other