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 |