FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 796778
·
Received December 13, 2006
Report
- Report Number
- 2936999-2006-00925
- Event Type
- Injury
- Date Received
- December 13, 2006
- Date of Event
- December 3, 2006
- Report Date
- December 4, 2006
- Manufacturer
- JUAREZ HENEQUEN
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS COMPLAINT IS CURRENTLY IN PROGRESS.
Description of Event or Problem · 1
ON 12/04/2006, NELLCOR PURITAN BENNETT RECEIVED A REPORT OF HUB SEPARATION ON A TRACHEOSTOMY TUBE. THE CALLER REPORTED THAT THE TUBE SEPARATED FROM THE HUB AND THE PATIENT HAD TO BE RE-INTUBATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY | TRACHEOSTOMY TUBE | BTO | JUAREZ HENEQUEN | LPC | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |