MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-21 for RESISTICK BLADE * ES01-TM manufactured by Aaron Medical.
[32415]
During the dissection of left tonsil, it was noted that the shaft of the resistick modified. Blade tip was burning the mucosa of the left inside cheek. Pt discharged to home same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 52693 |
| MDR Report Key | 52693 |
| Date Received | 1996-08-21 |
| Date of Report | 1996-05-02 |
| Date of Event | 1996-05-01 |
| Date Facility Aware | 1996-05-01 |
| Report Date | 1996-05-02 |
| Date Added to Maude | 1996-12-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESISTICK BLADE |
| Generic Name | RESISTICK BLADE MODIFIED |
| Product Code | KBL |
| Date Received | 1996-08-21 |
| Model Number | * |
| Catalog Number | ES01-TM |
| Lot Number | 0296 B |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 53331 |
| Manufacturer | AARON MEDICAL |
| Manufacturer Address | 7100 30TH AVE NORTH ST PETERSBURG FL 337102902 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-08-21 |