MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-24 for INSTATRAK STRAIGHT ASPIRATOR ENT-100AS-01 manufactured by Visualization Technology Inc..
[43844]
Device accuracy was off by several millimeters during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 53043-1997-00002 |
| MDR Report Key | 68102 |
| Report Source | 05 |
| Date Received | 1997-01-24 |
| Date of Report | 1997-01-07 |
| Date of Event | 1997-01-07 |
| Date Mfgr Received | 1997-01-07 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTATRAK STRAIGHT ASPIRATOR |
| Generic Name | ASPIRATOR/POINTER |
| Product Code | MGI |
| Date Received | 1997-01-24 |
| Model Number | NA |
| Catalog Number | ENT-100AS-01 |
| Lot Number | JAZ6263-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 68106 |
| Manufacturer | VISUALIZATION TECHNOLOGY INC. |
| Manufacturer Address | 30 G SIXTH RD WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-24 |