FDA Adverse Event Injury Summary report: N

COVIDIEN

MDR report key: 2434452 · Received January 24, 2012

Report

Report Number
MW5024041
Event Type
Injury
Date Received
January 24, 2012
Date of Event
November 15, 2011
Manufacturer
COVIDIEN
Product Code
GDW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ANASTOMOTIC LEAK OCCURRED CAUSING READMISSION, MALNUTRITION DELAY IN CHEMOTHERAPY AND SIGNIFICANT PELVIC PAIN. REASON FOR USE: RECTAL CANCER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COVIDIEN EEA 31MM STAPLE GDW COVIDIEN
2 COVIDIEN ENDO GIA 60+45MM PURPLE STAPLE LOAD GDW COVIDIEN

Patients

Seq Age Sex Outcome Treatment
1 56 YR Hospitalization| L| O