MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-23 for EXONIX ULTRASONIC SURGICAL SYSTEM * manufactured by Fibra-sonics.
[19953354]
Doctor received a second degree burn on the back of his hand (size unk), when he touched the device applicator to back of his hand to test how hot the applicator had become.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419218-1999-00002 |
| MDR Report Key | 242135 |
| Date Received | 1999-09-23 |
| Date of Report | 1999-09-22 |
| Date of Event | 1999-09-08 |
| Date Facility Aware | 1999-09-08 |
| Report Date | 1999-09-22 |
| Date Mfgr Received | 1999-09-21 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 1999-09-29 |
| 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 |
| Manufacturer Street | 5312 N. ELSTON AVE |
| Manufacturer City | CHICAGO IL 60630 |
| Manufacturer Country | US |
| Manufacturer Postal | 60630 |
| Manufacturer Phone | 7732867377 |
| Manufacturer G1 | FIBRA SONICS |
| Manufacturer Street | 5312 N. ELSTON AVE |
| Manufacturer City | CHICAGO IL 60630 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60630 |
| 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 | 1999-09-23 |
| Model Number | EXONIX |
| Catalog Number | * |
| Lot Number | NI |
| ID Number | NA |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 234596 |
| Manufacturer | FIBRA-SONICS |
| Manufacturer Address | 5312 N. ELSTON AVE. 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. Other | 1999-09-23 |