FDA Adverse Event
Injury
Summary report: N
TAPERGUARD EVAC
MDR report key: 2201970
·
Received August 4, 2011
Report
- Report Number
- 2936999-2011-00507
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 8, 2011
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K090352
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER IS UNK, THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. THE TUBE WAS DISCARDED BY THE USER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE CUFFS WOULD FALL OFF THE GLOTTIS OF THE PT AND THE AIR LEAK ALARM WOULD BE ACTIVATED. THE TUBE WAS NOT REMOVED AND THEY USED TAPE OF "TAPING" TO STABILIZE. IT WAS REPORTED THAT THE PT WAS RE-INTUBATED WITHOUT FURTHER INCIDENT. THE SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAPERGUARD EVAC | ENDOTRACHEAL TUBE | BTR | COVIDIEN/FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |