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 |