FDA Adverse Event
Injury
Summary report: N
PORTEX SPINAL ANESTHESIA TRAYS
MDR report key: 3021065
·
Received March 15, 2013
Report
- Report Number
- 2183502-2013-00094
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- CAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- UNKNOWN
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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT STATED THAT PATIENT RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE THE PATIENT UNDER AN ALTERNATIVE ANESTHESIA DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110675 | PORTEX SPINAL ANESTHESIA TRAYS | CAZ - ANESTHESIA KIT, SPINAL | CAZ | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |