FDA Adverse Event
Injury
Summary report: N
PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS
MDR report key: 3021110
·
Received March 15, 2013
Report
- Report Number
- 2183502-2013-00101
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- January 3, 2013
- Report Date
- March 12, 2013
- Manufacturer
- SMITHS MEDICAL ADS, INC.
- Product Code
- CAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PATIENTS RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO USE GENERAL ANESTHESIA DURING THE PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110555 | PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS | CAZ - ANESTHESIA CONDUCTION KIT | CAZ | SMITHS MEDICAL ADS, INC. | NA | 2357227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |