FDA Adverse Event
Other
Summary report: N
SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T
MDR report key: 221751
·
Received July 23, 1999
Report
- Report Number
- 2029387-1999-00043
- Event Type
- Other
- Date Received
- July 23, 1999
- Date of Event
- February 22, 1999
- Report Date
- March 8, 1999
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS IS THE MANUFACTURERS SECOND FOLLOW-UP REPORT TO PROVIDE ADDITIONAL INFO STATUS INVOLVING A PRODUCT ADVISORY REMEDIAL ACTION..
Description of Event or Problem · 1
THE 8 DCT DEVICE WAS RETURNED TO THE MFR ON 3/25/1999 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. THE DEVICE EVAL RESULTS ARE RECORDED ON SECTION H. OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T Implant | TRACHEOSTOMY TUBE | BTO | MALLINCKRODT MEDICAL, INC. | 8 DCT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |