FDA Adverse Event
Malfunction
Summary report: N
RUSCH ET. TUBE REINFORCE CUFFED NASORAL 6.5MM
MDR report key: 2152512
·
Received June 21, 2011
Report
- Report Number
- 9610520-2011-00006
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 30, 2011
- Report Date
- June 14, 2011
- Manufacturer
- WILLY RUESCH GMBH
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT REC'D BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED COMPLAINT: "IN THE EMERGENCY UNIT, DURING THE TEST PRIOR TO USE, IT WAS DIFFICULT TO INFLATE AND DEFLATE THE BALLOON. A NEW TUBE WAS SUCCESSFULLY USED, NO CONSEQUENCE FOR THE PT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH ET. TUBE REINFORCE CUFFED NASORAL 6.5MM | ENDOTRACHEAL TUBE | BTR | WILLY RUESCH GMBH | NA | 9071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |