MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-09 for BITE-BLOCK 1009 manufactured by Sontek Medical, Inc..
[17427982]
Pt developed leak in ett cuff. Staff unable to inject air through pilot balloon. Pt extubated and reintubated. Pilot balloon tube found kinked under bite block.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001002 |
| MDR Report Key | 11902 |
| Date Received | 1994-03-09 |
| Date of Report | 1994-02-18 |
| Date of Event | 1994-01-18 |
| Date Added to Maude | 1994-03-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE-BLOCK |
| Product Code | BRW |
| Date Received | 1994-03-09 |
| Model Number | NA |
| Catalog Number | 1009 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11902 |
| Manufacturer | SONTEK MEDICAL, INC. |
| Manufacturer Address | HINGHAM MA 02043 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-09 |