FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 2465285
·
Received February 16, 2012
Report
- Report Number
- 8040409-2012-00001
- Event Type
- Injury
- Date Received
- February 16, 2012
- Date of Event
- February 2, 2012
- Report Date
- February 15, 2012
- Manufacturer
- NIRAJ INDUSTRIES PVT LTD
- Product Code
- GES
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION OF THIS EVENT IS STILL IN PROCESS BY THE MANUFACTURER'S US AGENT. ATTEMPTS WILL BE MADE TO OBTAIN THE LOT NUMBER, EXPIRATION DATE, AND FURTHER DETAILS OF THE EVENT FROM THE COMPLAINANT. AS MORE INFO IS PROVIDED THIS FORM WILL BE UPDATED AND SUBMITTED TO THE FDA AS REQUIRED.
Description of Event or Problem · 1
THE DOCTOR LACERATED HER HAND TRYING TO REMOVE A CAP OFF A SCALPEL. SHE REQUIRED 6 STITCHES AT THE EMERGENCY ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HENRY SCHEIN | #12 SCAPEL STERILE | GES | NIRAJ INDUSTRIES PVT LTD | HSI6008-12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |