MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-30 for INVENIA SCAN STATION ABUS manufactured by Ge.
[18037550]
Patient voluntarily underwent an ultrasound of the breast as a test patient for the abus. There were no complaints immediately following the ultrasound. She tolerated the procedure well. Three days later the patient and her husband noted that the right breast changed in appearance. Of note the patient has silicone, part saline implants from 1989. The patient subsequently was seen by her previous plastic surgeon and determined that the right implant was leaking. She alleges this occurred due to the abus. The patient has since undergone a replacement of her implant. Concomitant medical products: breast implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043562 |
| MDR Report Key | 4895049 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-03-25 |
| Date Added to Maude | 2015-07-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVENIA SCAN STATION ABUS |
| Generic Name | INVENIA SCAN STATION ABUS |
| Product Code | PAA |
| Date Received | 2015-06-30 |
| ID Number | USYN1400079 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-30 |