MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-06-01 for EXONIX ULTRASONIC SURGICAL SYSTEM * manufactured by Fibra-sonics.
[15705668]
Pt rec'd 2 third degree burns on flank estimated in size 6 cm x 10 cm. The burn is all in one area with different levels of severity within the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419218-1999-00001 |
| MDR Report Key | 225594 |
| Report Source | 08 |
| Date Received | 1999-06-01 |
| Date of Report | 1999-05-28 |
| Date of Event | 1999-05-06 |
| Date Facility Aware | 1999-05-12 |
| Report Date | 1999-05-28 |
| Date Mfgr Received | 1999-05-12 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 1999-06-03 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXONIX ULTRASONIC SURGICAL SYSTEM |
| Generic Name | ULTRASONIC DIATHERMY |
| Product Code | IMI |
| Date Received | 1999-06-01 |
| Returned To Mfg | 1999-05-20 |
| Model Number | EXONIX |
| Catalog Number | * |
| Lot Number | 8C |
| ID Number | NA |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 218762 |
| Manufacturer | FIBRA-SONICS |
| Manufacturer Address | 5312 NORTH ELSTON CHICAGO IL 60630 US |
| Baseline Brand Name | EXONIX |
| Baseline Generic Name | DIATHERMY, ULTRASONIC |
| Baseline Model No | EXONIX |
| Baseline Catalog No | 89-8200 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915557 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-01 |