MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-15 for TRANSTRACHEAL SYSTEMS T-9 NA manufactured by Transtracheal Systems.
[194761]
Pt prepped for transtracheal oxygen device placement. Kit did not contain transtracheal oxygen stent. Scoop tube #9 was used after trimming external tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017178 |
| MDR Report Key | 241018 |
| Date Received | 1999-09-15 |
| Date of Report | 1999-09-14 |
| Date of Event | 1999-09-14 |
| Date Added to Maude | 1999-09-22 |
| 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 |
| 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 | TRANSTRACHEAL SYSTEMS |
| Generic Name | SCOOP PROCEDURE TRAY |
| Product Code | KCG |
| Date Received | 1999-09-15 |
| Model Number | T-9 |
| Catalog Number | NA |
| Lot Number | 0339 |
| ID Number | * |
| Device Expiration Date | 2003-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 233541 |
| Manufacturer | TRANSTRACHEAL SYSTEMS |
| Manufacturer Address | 109 INVERNESS DRIVE EAST STE J ENGLEWOOD CO 801125105 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-09-15 |