MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-05-19 for MK2 - EXABLATE EXABLATE 2000 NA manufactured by Insightec-txsonics.
[208015]
Patient was being treated with as part of a clinical study mr guided focused ultrasound of breast cancer. Nine days before event date, patient underwent focused ultrasound ablation of the primary tumor site. Two days before event date patient underwent right breast partial mastectomy and sentinel lymph node mapping and excision. Their initial postoperative course was uneventful. Forty hour postoperatively, patient awoke at 1:30 a. M. And noted that their right breast was rapidly swelling. Patient was sent by ambulance to the hospital. On exam in the emergency room, their right breast was distended, tense, and ecchymotic laterally, consistent with a hematoma. Their was brought to the operating room for right breast exploration with hematoma evacuation. The patient remained in the hospital overnight for observation. No further complications were noted and the patient was discharged home 3 days after event date for normal follow-up of breast cancer treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651378-2001-00001 |
| MDR Report Key | 334428 |
| Report Source | 07 |
| Date Received | 2001-05-19 |
| Date of Report | 2001-05-18 |
| Date of Event | 2001-04-26 |
| Date Added to Maude | 2001-05-25 |
| 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 | ROBERT NEWMAN |
| Manufacturer Street | 2777 STEMMONS FRWY #940 |
| Manufacturer City | DALLAS TX 75207 |
| Manufacturer Country | US |
| Manufacturer Postal | 75207 |
| Manufacturer Phone | 2146302000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MK2 - EXABLATE |
| Generic Name | FOCUSED ULTRASOUND THERAPY |
| Product Code | MIK |
| Date Received | 2001-05-19 |
| Model Number | EXABLATE 2000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323772 |
| Manufacturer | INSIGHTEC-TXSONICS |
| Manufacturer Address | 7 ETGAR ST. EINSTEIN BLDG NEW INDUSTRIAL ZONE TIRAT CARMEL IS 39120 |
| Baseline Brand Name | MK2 - EXABLATE |
| Baseline Generic Name | NA |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-05-19 |