FDA Adverse Event
Malfunction
Summary report: N
U2 STRAIGHT MEDIUM M ATTACHMENT
MDR report key: 1842029
·
Received August 26, 2010
Report
- Report Number
- 1811755-2010-01024
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- August 5, 2010
- Report Date
- August 5, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL ATTACHMENT WAS NOT RETURNED TO THE MFR FOR AN INVESTIGATION, BECAUSE THE USER FACILITY DISCARDED THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED TO THE USER FACILITY'S STERILE PROCESSING DEPARTMENT, THAT THE DRILL ATTACHMENT HEATED UP. NO INFO IS KNOWN ABOUT PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U2 STRAIGHT MEDIUM M ATTACHMENT | DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |