FDA Adverse Event
Injury
Summary report: N
PORTEX SPINAL ANESTHESIA TRAYS
MDR report key: 1871216
·
Received October 11, 2010
Report
- Report Number
- 2183502-2010-00442
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- September 9, 2010
- Report Date
- October 8, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- CAZ
- PMA / PMN Number
- PREAMENDMENT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT STATED THAT A PT REC'D INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE THE PT UNDER GENERAL ANESTHESIA DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX SPINAL ANESTHESIA TRAYS | CAZ - ANESTHESIA CONDUCTION KIT | CAZ | SMITHS MEDICAL ASD, INC. | NA | 1668276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |