MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-01-29 for EXONIX EXTERNAL ULTRASONIC SURGICAL SYSTEM 89-8200 manufactured by Genzyme Surgical Products.
[164650]
"ual" procedure of arms, inner thighs, hips, and abdomen was performed on october 20. It was noticed at the end of the procedure while dressings were applied that patient's right arm had a superficial blister. This was treated with antibiotic ointment and nonstick gauze dressing. The day after the procedure, a health professional became aware that the patient suffered a third degree burn approx 10 cm x 4. 5cm x 0. 3 cm 1 to the hip secondary to external ultrasound and liposuction. The burn was excised on november 16; the underlying fat appeared to be normal and showed no evidence of damage from the liposuction. Surgeon also stated that the standard power was used but with a reduced contact time and there were no technical errors observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038548-1999-00001 |
| MDR Report Key | 207957 |
| Report Source | 05,06,07 |
| Date Received | 1999-01-29 |
| Date of Report | 1999-01-29 |
| Date of Event | 1998-10-20 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 1999-02-01 |
| 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 EXTERNAL ULTRASONIC SURGICAL SYSTEM |
| Generic Name | ULTRASONIC DIETHERMY |
| Product Code | IMI |
| Date Received | 1999-01-29 |
| Returned To Mfg | 1999-01-08 |
| Model Number | NA |
| Catalog Number | 89-8200 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201842 |
| Manufacturer | GENZYME SURGICAL PRODUCTS |
| Manufacturer Address | 5175 SOUTH ROYAL ATLANTA DR. TUCKER GA 30084 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 | 1999-01-29 |