FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1012138
·
Received February 20, 2008
Report
- Report Number
- 9617604-2008-00009
- Event Type
- Malfunction
- Date Received
- February 20, 2008
- Manufacturer
- SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- BTR
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
RESULTS EVALUATION: THE SAMPLE HAS BEEN REC'D AND THE INVESTIGATION HAS NOT BEEN COMPLETED. PRELIMINARY FINDINGS CONFIRM THE REPORTED LEAKAGE. THE LEAKAGE WAS LOCATED AT THE BONDING PORTION BETWEEN THE CUFF AND THE TUBE. THE SKIRT OF THIS PORTION WAS FOUND TO HAVE COME PARTIALLY UNSTUCK. UPON THE COMPLETION OF THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | BTR | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |