MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PREATTACHED LEADWIRE ELECTRODE, MEDIUM

Model Number 13952E

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

The customer customer that the pediatric pt suffered a burn requiring a skin graft during use of the 13952e prewired electrodes.

Manufacturer Narrative

(b)(4).A follow-up report will be submitted once the investigation is completed.

• Brand Name: PREATTACHED LEADWIRE ELECTRODE, MEDIUM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: nancy ataid ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 3763323
• MDR Text Key: 4549089
• Report Number: 1218950-2014-01900
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K900682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2014

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: Other
• Device Model Number: 13952E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR