FDA Adverse Event
Injury
Summary report: N
COMPRESSION ANASTOMOSIS RING
MDR report key: 2240627
·
Received August 25, 2008
Report
- Report Number
- 3005278776-2008-00006
- Event Type
- Injury
- Date Received
- August 25, 2008
- Date of Event
- July 23, 2008
- Report Date
- August 5, 2008
- Manufacturer
- NITI SURGICAL SOLUTIONS LTD.
- Product Code
- FZP
- PMA / PMN Number
- K062008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO CORRECTIVE ACTION OR REMEDIAL ACTIONS. MINOR LEAKS ARE COMMON ADVERSE EVENTS IN THIS KIND OF PROCEDURE.
Description of Event or Problem · 1
ANASTOMOTIC LEAK - PURSE STRING TO PURSE STRING. THE NATURE OF THE LEAK IS UNCLEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPRESSION ANASTOMOSIS RING | CAR 27 | FZP | NITI SURGICAL SOLUTIONS LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization |