MAUDE Adverse Event Report: COVIDIEN KENDALL ELECTRO PADS; ELECTRODE, EKG

Catalog Number 22855

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Foam electrode pads did not adhere to the patient.The rep was informed and now there is a new trial with new pads.

• Brand Name: KENDALL ELECTRO PADS
• Type of Device: ELECTRODE, EKG
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4963220
• MDR Text Key: 20032892
• Report Number: 4963220
• Device Sequence Number: 1
• Product Code: DRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 22855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2015
• Patient Sequence Number: 1
• Patient Age: 34 YR