MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-02-14 for EXONIX EXTERNAL ULTRASONIC SYSTEM 89-8200 manufactured by Genzyme Biosurgery.
[18448631]
The reporter stated the ultrasound head was used approx 15 times and has begun to overheat and burn pts when in contact with their skin. Additional info was received on 2/14/2001 that this issue occurred seven times. The pts experienced mild burns and discomfort. The same device was used in each occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038548-2001-00007 |
| MDR Report Key | 315671 |
| Report Source | 05,06 |
| Date Received | 2001-02-14 |
| Date of Report | 2001-01-23 |
| Date of Event | 2001-01-23 |
| Date Mfgr Received | 2001-01-23 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 2001-02-15 |
| 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 Contact | PETE STEGAGNO |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER GA 30084 |
| Manufacturer Country | US |
| Manufacturer Postal | 30084 |
| Manufacturer Phone | 7707232778 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXONIX EXTERNAL ULTRASONIC SYSTEM |
| Generic Name | ULTRASONIC DIETHERMY |
| Product Code | IMI |
| Date Received | 2001-02-14 |
| Model Number | NA |
| Catalog Number | 89-8200 |
| Lot Number | 98275007-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 305261 |
| Manufacturer | GENZYME BIOSURGERY |
| Manufacturer Address | 5175 SOUTH ROYAL ATLANTA DR TUCKER GA 300843053 US |
| Baseline Brand Name | EXONIX EXTERNAL ULTRASONIC SURGICAL SYSTEM |
| Baseline Generic Name | ULTRASONIC DIETHERMY |
| Baseline Model No | NA |
| Baseline Catalog No | 89-8200 |
| Baseline ID | * |
| Baseline Device Family | DEEP HEATING THERAPEUTIC UNIT |
| 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 | 2001-02-14 |