FDA Adverse Event
Injury
Summary report: N
SHILEY-TRACHEOSTOMY TUBE
MDR report key: 232969
·
Received May 18, 1999
Report
- Report Number
- 232969
- Event Type
- Injury
- Date Received
- May 18, 1999
- Date of Event
- July 28, 1998
- Report Date
- July 29, 1998
- Manufacturer
- MALLINCKRODT MEDICAL TPI, INC.
- Product Code
- BTR
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PT WAS BEING TURNED IN THE BED TO REMOVE HER FROM THE BED PAN. SHE HAD A SHILEY TRACH TUBE IN PLACE. IT BECAME DISLODGED AND THE PT DEVELOPED SUBCUTANEOUS EMPHYSEMA SYSTEMATICALLY AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND REPLACEMENT OF TRACH. SHE WAS TO BE TRANSFERRED TO A LONG TERM VENTILATORY SUPPORT FACILITY. HER TANSFER WAS CANCELLED. SHE WAS AND REMAINS IN INTENSIVE CARE UNIT. 7/29 HAS IMPROVED AFTER INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY-TRACHEOSTOMY TUBE Implant | DISPOSABLE TRACHEOSTOMY TUBE #* DFF | BTR | MALLINCKRODT MEDICAL TPI, INC. | * | M81322000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| L| R | MIDLINE CATHETER/INT.| DOBBHOFF FEEDING TUBE, 7/13/98,| VENTILATORY CPAP PS-10, 7/28/98, |