FDA Adverse Event Malfunction Summary report: N

SNOWDEN PENCER RIGHT ANGLE LIGHTED

MDR report key: 3786122 · Received April 25, 2014

Report

Report Number
3786122
Event Type
Malfunction
Date Received
April 25, 2014
Date of Event
February 13, 2014
Report Date
April 25, 2014
Manufacturer
CAREFUSION 2200 INC
Product Code
GAD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

SURGEON REQUESTED LIGHTED RETRACTOR DURING THE SURGERY. PHYSICIAN PERFORMING SUBSEQUENT RECONSTRUCTION SURGERY NOTICED BLISTER ON PATIENT'S RIGHT CHEST THAT MAY BE A BURN. ORDERED SILVADENE CREAM POSTOP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
251885 SNOWDEN PENCER RIGHT ANGLE LIGHTED RETRACTOR, FIBEROPTIC GAD CAREFUSION 2200 INC * *
251886 CIRCON LIGHT, SURGICAL, CARRIER GAD GYRUS ACMI, INC G93 *

Patients

Seq Age Sex Outcome Treatment
1 44 YR