FDA Adverse Event
Other
Summary report: N
TYCO HEALTHCARE
MDR report key: 1621613
·
Received February 25, 2010
Report
- Report Number
- MW5014949
- Event Type
- Other
- Date Received
- February 25, 2010
- Date of Event
- February 19, 2010
- Report Date
- February 25, 2010
- Manufacturer
- TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIV.
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
TRACHEOSTOMY TUBE WAS INSERTED IN PT ON (B) (6) 2010 AND HAD TO BE REPLACED ON (B) (6) 2010 BECAUSE, THE CUFF WOULD NOT HOLD AIR. SHILEY # 6 LPC, (B) (4). DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: VENTILATOR SUPPORT AIRWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TYCO HEALTHCARE | SHILEY #6 LPC | JOH | TYCO HEALTHCARE GROUP LP NELLCOR PURITAN BENNETT DIV. | LPC | 0902001779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |