MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-30 for MAMOSITE 2056 * manufactured by Proxima.
[17436884]
Post radiation therapy - pt had 5-6cm balloon inserted without problem (volume 90cc). Post placement ct scan perfect, received treatment. While out shopping pt heard a "pop" and then noted fluid soaking their blouse. Ultrasound in office showed partly deflated balloon. Assumed mechanical structural failure of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030698 |
| MDR Report Key | 506515 |
| Date Received | 2003-12-30 |
| Date of Report | 2003-12-12 |
| Date of Event | 2003-12-11 |
| Date Added to Maude | 2004-01-16 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMOSITE |
| Generic Name | BREAST RADIATION DEVICE |
| Product Code | MOU |
| Date Received | 2003-12-30 |
| Model Number | 2056 |
| Catalog Number | * |
| Lot Number | P02113B |
| ID Number | REF 2056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 495387 |
| Manufacturer | PROXIMA |
| Manufacturer Address | 2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 30005 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-30 |