FDA Adverse Event
Injury
Summary report: N
MCGRATH
MDR report key: 9180543
·
Received October 11, 2019
Report
- Report Number
- 3010244187-2019-00017
- Event Type
- Injury
- Date Received
- October 11, 2019
- Date of Event
- July 7, 2017
- Report Date
- October 11, 2019
- Manufacturer
- AIRCRAFT MEDICAL LIMITED
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TITLE A COMPARATIVE STUDY OF MCGRATH AND AIRTRAQ VIDEOLARYNGOSCOPES FOR TRACHEAL INTUBATION SOURCE JOURNAL OF ANAESTHESIOLOGY CLINICAL PHARMACOLOGY, VOLUME 33, 2017 (221-225) ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE LITERATURE, THE STUDY WAS DESIGNED TO COMPARE THE PERFORMANCE OF TWO UNITS. THERE WAS THREE CASES WITH BLOOD ON THE LARYNGOSCOPE BLADE, THERE WAS AN INCREASE IN HEART RATE AND MEAN ARTERIAL BLOOD PRESSURE AFTER TRACHEAL INTUBATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974144 | MCGRATH | LARYNGOSCOPE, RIGID | CCW | AIRCRAFT MEDICAL LIMITED | 300-000-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |