FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE
MDR report key: 1905683
·
Received November 12, 2010
Report
- Report Number
- 9610726-2010-00429
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- March 5, 2010
- Report Date
- October 20, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "(B)(4) SIMPLEX WITH TOBRAMYCIN - 10 PACK WAS REC'D AND WAS DAMAGED. IT APPEARS THAT 2 OF THE 10 VIALS WERE BROKEN INSIDE THE PACKS AND SOMEHOW LEAKED THROUGH CAUSING DAMAGE TO A TOTAL OF 3 OF THE 10 IN THE BOX. HOSPITAL WILL DESTROY ON SITE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MIR048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |