FDA Adverse Event
Injury
Summary report: N
PORTEX SPINAL ANESTHESIA TRAYS
MDR report key: 3131373
·
Received May 13, 2013
Report
- Report Number
- 2183502-2013-00221
- Event Type
- Injury
- Date Received
- May 13, 2013
- Date of Event
- March 7, 2013
- Report Date
- May 10, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- CAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THAT A PT RECEIVED 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 |
|---|---|---|---|---|---|---|---|
| 211668 | PORTEX SPINAL ANESTHESIA TRAYS | CAZ - ANESTHESIA KIT SPINAL | CAZ | SMITHS MEDICAL ASD, INC | NA | 2372186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |