MAUDE Adverse Event Report: COVIDIEN 7605 BIOTAC CL 50/P 600/C; ELECTRODES

Model Number 31043170

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Scarring (2061); Burning Sensation (2146); Rupture (2208)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with electrodes.The customer reports that a burning sensation occurs when the electrode is attached to the skin.Some patients have developed rashes and/or ruptured skin and/or scarring.Additional information has been requested with no response to date.

Manufacturer Narrative

Per additional information received on 12/20/2016 the customer stated that one patient came back after a year and you could see square outlines on their skin.She does not know what was used, if anything to treat the rash/scarring.The customer stated anecdotally that on some types of skin (sensitive skin) the rashes and scarring have occurred in the past; however, there is no specific information available to provide.

• Brand Name: 7605 BIOTAC CL 50/P 600/C
• Type of Device: ELECTRODES
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; two ludlow park drive; chicopee MA 01022
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6187543
• MDR Text Key: 62793474
• Report Number: 1219103-2016-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31043170
• Device Catalogue Number: 31043170
• Device Lot Number: 614109X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other