FDA Adverse Event Injury Summary report: N

OPTIVANTAGE DH

MDR report key: 1852402 · Received September 28, 2010

Report

Report Number: 1518293-2010-00122
Event Type: Injury
Date Received: September 28, 2010
Date of Event: September 3, 2010
Report Date: September 3, 2010
Manufacturer: LIEBEL-FLARSHEIM CO.
Product Code: IZQ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COVIDIEN PRODUCT MONITORING F/U WITH THE FACILITY (B)(4) WHO STATED THEY DO NOT NEED THE INJECTOR EVALUATED. THERE WAS NO PROBLEM WITH THE INJECTOR. THE (B)(4) ALSO STATED THEY DO NOT BELIEVE THE INJECTOR WAS THE CAUSE OF THE INFILTRATION, INSTEAD THEY BELIEVE A BAD IV POSITION WAS THE CAUSE. SYSTEM IS IN FULL USE BY THE CUSTOMER.

Description of Event or Problem · 1

ON 09/03: CUSTOMER REPORTS VIA PHONE, (B)(6) REC'D OPTIRAY 350 FOR CT AND APPROX 20ML INFILTRATED INTO THE BACK OF THE HAND. PT HAS SWELLING IN THE BACK OF THE HAND UP INTO THE FOREARM. PT BEING CONSULTED BY SURGEON IN THE EMERGENCY ROOM. ON 9/10: CUSTOMER REPORTS THE FOLLOWING BASIC INFORMATION ONLY; PT HAVING A CT CONTRAST INJECTION, WHEN TECHNOLOGIST NOTED SKIN COLORING CHANGING AS THE INJECTION PROGRESSED. PT DID NOT DEVELOP ANY IMMEDIATE SWELLING AS NOTED BY THE TECHNOLOGIST. INJECTION STOPPED, ARM ELEVATED, WARM COMPRESS APPLIED AND PT TAKEN TO ER FOR EVALUATION. ER PHYSICIAN AND SURGEON REPORTS THE BACK OF THE HAND, UP THE PROXIMAL FOREARM STARTING TO SWELL UP. CUSTOMER REPORTS THE PT DID GO TO SURGERY FOR RELIEF OF COMPARTMENTALIZATION. APPROX 40ML INFILTRATION. CUSTOMER REPORTS THAT PT IS DOING FINE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTIVANTAGE DH	CT POWER INJECTOR SYSTEM	IZQ	LIEBEL-FLARSHEIM CO.	OPTIVANTAGE DH	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention