FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1971452
·
Received January 20, 2011
Report
- Report Number
- 2936999-2011-00059
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 22, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K082520
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFO IS BEING CONFIRMED AND IF ANY NEW AND/OR SIGNIFICATION INFO IS PROVIDED, INFO WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE SAMPLE AND LOT# ASSOCIATED TO THIS REPORT IS NOT AVAILABLE FOR INVESTIGATION.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF DEVELOPED A LEAK. THE CALLER REPORTED THAT HE THINKS REPLACEMENT OF THE TUBE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | SEALGUARD ENDOTRACHEAL TUBE | BTR | COVIDIEN, FORMERLY TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |