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

Model Number 31013926

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Tissue Damage (2104); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694)

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, possible burns, while using this product.The pt was seen in the emergency department immediately.The pt was prescribed hyderm cream 1 percent by the physician he saw in the emergency room on (b)(6) 2014.Blistering, oozing, redness, were all noted on the pt's skin and it was very painful.The customer further reports that the nurses notes from the emergency room state: 2 noticeable red burns from lead stickers.Area painful ice packs, no drainage.The doctors notes state desquamated well demarcated erythematous lesion x 7 on chest and ribs.

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: ELECTRODES
• Manufacturer (Section D): COVIDIEN; 215 herbert street; gananoque, on K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 herbert st.; gananoque, on KYG ; CA KYG
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3736620
• MDR Text Key: 4221571
• Report Number: 9681860-2014-00004
• 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: 04/02/2014
• 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?: No
• 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