FDA Adverse Event
Injury
Summary report: N
KERRISON RONGEUR, X-SMALL, SZ 0
MDR report key: 412566
·
Received August 23, 2002
Report
- Report Number
- 1423507-2002-00109
- Event Type
- Injury
- Date Received
- August 23, 2002
- Date of Event
- August 5, 2002
- Report Date
- August 20, 2002
- Manufacturer
- ALLEGIANCE HEALTHCARE CORP
- Product Code
- KBB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN EYE CASE, THE TIP OF THE DEVICE BROKE OFF, AS THE PHYSICIAN WAS CHIPPING AT BONE FOR THE PURPOSE OF INSERTING TUBES. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE FOREIGN BODY. THE PT IS SCHEDULED TO HAVE FOREIGN BODY REMOVED AT LATER DATE BY AN ENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERRISON RONGEUR, X-SMALL, SZ 0 | INSTRUMENT | KBB | ALLEGIANCE HEALTHCARE CORP | AU6769 | X02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other| R |