FDA Adverse Event
Other
Summary report: N
HIBBS CHISEL 9-1/2 ST 3/8
MDR report key: 2281796
·
Received October 3, 2011
Report
- Report Number
- 2523190-2011-00067
- Event Type
- Other
- Date Received
- October 3, 2011
- Report Date
- October 3, 2011
- Manufacturer
- INTEGRA YORK - MILTEX
- Product Code
- EML
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
CUSTOMER SERVICE REP AT THE DISTRIBUTOR'S OFFICE, WAS EXAMINING THE DEVICE. WHEN SHE PUT THE PROTECTIVE COVER BACK ON THE TIP OF THE CHISEL SHE WAS INJURED. TIP WENT THROUGH THE COVER, WHICH SHE BELIEVES WAS ALREADY SLIT. SHE DESCRIBES HER INJURY AS "NON LIFE THREATENING, SIMILAR TO A PAPER CUT". THERE WAS POTENTIAL FOR GREATER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIBBS CHISEL 9-1/2 ST 3/8 | M10 - ORTHOPEDIC | EML | INTEGRA YORK - MILTEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |