FDA Adverse Event
Injury
Summary report: N
LASER FLEX
MDR report key: 185143
·
Received August 25, 1998
Report
- Report Number
- 185143
- Event Type
- Injury
- Date Received
- August 25, 1998
- Date of Event
- July 1, 1998
- Report Date
- August 18, 1998
- Manufacturer
- MALLINCKRODT MEDICAL
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FACILITY REPORTED, "CUFF WOULD NOT DEFLATE, COULDN'T EXTUBATE, HAD TO DO A DIRECT LARYNGOSCOPY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASER FLEX | ENDOTRACHEAL TUBE | BTR | MALLINCKRODT MEDICAL | NA | ML07760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other| R |