FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN DISPOSABLE SCALPEL #12B
MDR report key: 2275986
·
Received September 30, 2011
Report
- Report Number
- 8040409-2011-00001
- Event Type
- Injury
- Date Received
- September 30, 2011
- Date of Event
- August 30, 2011
- Report Date
- September 13, 2011
- Manufacturer
- M/S NIRAJ INDUSTRIES PVT LTD.
- Product Code
- GES
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS EVENT IS ONGOING BY THE MFR'S US AGENT. AN ATTEMPT IS BEING MADE BY THE AGENT TO GAIN ADDITIONAL INFO ON THE DEVICE, CONDITION OF THE DOCTOR, AND AN ATTEMPT IS UNDERWAY TO RECOVER THE DEVICE FOR EXAMINATION BY THE MFR. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS CONCLUDED, OR IF NEW INFO IS DISCOVERED AS A RESULT OF THE INVESTIGATION.
Description of Event or Problem · 1
DOCTOR WENT TO RECAP SURGICAL BLADE AFTER PROCEDURE AND THE BLADE WENT THROUGH THE PLASTIC CAP AND CUT HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HENRY SCHEIN DISPOSABLE SCALPEL #12B | DISPOSABLE SCALPEL | GES | M/S NIRAJ INDUSTRIES PVT LTD. | HSI6008-12B | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |