FDA Adverse Event
Other
Summary report: N
MADGIC LARYNGO-TRACHEAL MUCOSAL ATOMIZATION
MDR report key: 18399949
·
Received December 26, 2023
Report
- Report Number
- MW5149588
- Event Type
- Other
- Date Received
- December 26, 2023
- Report Date
- December 22, 2023
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CCT
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE (B)(6) CENTER FOR PATIENT SAFETY RECEIVED A "SAFETY REPORT" REGARDING THE MADGIC LARYNGO-TRACHEAL MUCOSA! ATOMIZATION DEVICE. THIS DEVICE DELIVERS LOCAL ANESTHETIC. THE ISSUE THE SITE REPORTED IS THAT THE SYRINGES THAT ATTACH TO THESE DEVICES ARE THE SAME LUER-LOK SYRINGES THAT MIGHT ATTACH TO AN IV. THEY ARE CONCERNED THAT SOMEONE COULD INADVERTENTLY ATTACH THE ANESTHETIC TO AN IV LINE OR THE IV DRUG TO THE MADGIC DEVICE. THE ODD THING IS THAT OTHER ANESTHESIA PROFESSIONALS USE THE PREFILLED DEVICE, NO PROBLEM. WE HAVE THE SAME TYPES OF PATIENTS HOSPITAL TO HOSPITAL. (B)(6). SUBMISSION ID:(B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2266332 | MADGIC LARYNGO-TRACHEAL MUCOSAL ATOMIZATION | LARYNGOTRACHEAL TOPICAL ANESTHESIA APPLICATOR | CCT | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |