MAUDE Adverse Event Report: COVIDIEN 530 MEDI-TRACE FM 30/PK 600/CA; ELECTRODE

Model Number 31013926

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Impaired Healing (2378)

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with an electrode.The customer reports that they had a pt who experienced fairly serious skin damage, possibly burns while using this product.The pt visited the family doctor on day 3 and was seen in the emergency department on day 6/7 due to poor healing.The customer reports the pt used a cortisone ointment and stopped using it after 3 days because of no effect.She switched to an over the counter antibiotic (polysporin) ointment, otherwise, just a clean gauze dressing.The customer further reports skin prep was with alcohol, trace prep (strip sandpaper).The customer further reports the pt had the holter monitor removed on (b)(6) 2014.The pt saw the doctor on (b)(6) 2014 and was prescribed betaderm.The betaderm did not help and the pt discontinued use after a couple of days.

Manufacturer Narrative

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

• Brand Name: 530 MEDI-TRACE FM 30/PK 600/CA
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque, on K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 herbert street; gananoque, on K7G ; CA K7G
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3736610
• MDR Text Key: 4220094
• Report Number: 9681860-2014-00003
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 31013926
• Device Catalogue Number: 31013926
• Device Lot Number: 319707X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other