FDA Adverse Event
Injury
Summary report: N
MCGRATH
MDR report key: 10441212
·
Received August 24, 2020
Report
- Report Number
- 3010244187-2020-00004
- Event Type
- Injury
- Date Received
- August 24, 2020
- Date of Event
- July 16, 2020
- Report Date
- August 24, 2020
- Manufacturer
- AIRCRAFT MEDICAL LIMITED
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE HAD A PHYSICAL DAMAGE. IT WAS REPORTED THAT THE PATIENT HAD 3 SUTURES ON THE SOFT PALATE. THERE WAS PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 909694 | MCGRATH | LARYNGOSCOPE, RIGID | CCW | AIRCRAFT MEDICAL LIMITED | 300-000-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |