FDA Adverse Event
Malfunction
Summary report: N
RUSCH LASERTUBUS 7.0MM
MDR report key: 3972833
·
Received April 28, 2014
Report
- Report Number
- 9610520-2014-00006
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 4, 2014
- Manufacturer
- WILLY RUSCH GMBH
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE LASER TUBE MATERIAL DELAMINATED FROM THE CORE OF THE TUBE WHILE IN A PT. THE PT WAS EXTUBATED. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253562 | RUSCH LASERTUBUS 7.0MM | ENDOTRACHEAL TUBE | BTR | WILLY RUSCH GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |