FDA Adverse Event
Injury
Summary report: N
EEA
MDR report key: 7271025
·
Received February 14, 2018
Report
- Report Number
- 2647580-2018-00721
- Event Type
- Injury
- Date Received
- February 14, 2018
- Date of Event
- November 17, 2017
- Report Date
- February 14, 2018
- Manufacturer
- US SURGICAL PUERTO RICO
- Product Code
- GDW
- UDI-DI
- 10884523005554
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE PATIENT UNDERGONE LAPAROSCOPIC SIGMOIDECTOMY AND HAD AN ANASTOMOSIS AT THE END OF THE PROCEDURE ON COLON TISSUE WHERE THE DEVICE WAS USED. ONE DAY POST-OPERATIVELY, PATIENT¿S HAB WENT FROM 133 TO 120. THERE WAS A TISSUE DAMAGED AND BLEEDING ON ANASTOMOSIS AND CONSERVATIVE TREATMENTS WERE DONE. ADDITIONAL OPERATION SHOULD PERFORM TO CORRECT THE ISSUE. PATIENT IS ALIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113609 | EEA | STAPLE, IMPLANTABLE | GDW | US SURGICAL PUERTO RICO | EEA31 | P7C0088KX | 10884523005554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |