MAUDE Adverse Event Report: COVIDIEN

Model Number UNK EL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

As per the report, the customer's son was badly burned by foam mini electrodes during hospitalization.

• Manufacturer (Section D): COVIDIEN; 2 ludlow rd.; chicopee MA 01020
• Manufacturer (Section G): COVIDIEN; 2 ludlow rd.; chicopee MA 01020
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6962386
• MDR Text Key: 89800922
• Report Number: 9681860-2017-05011
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK EL
• Device Catalogue Number: UNK EL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 10/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other