MAMOSITE 2056 *

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW1030698
MDR Report Key506515
Date Received2003-12-30
Date of Report2003-12-12
Date of Event2003-12-11
Date Added to Maude2004-01-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMAMOSITE
Generic NameBREAST RADIATION DEVICE
Product CodeMOU
Date Received2003-12-30
Model Number2056
Catalog Number*
Lot NumberP02113B
ID NumberREF 2056
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key495387
ManufacturerPROXIMA
Manufacturer Address2555 MARCONI DRIVE SUITE 220 ALPHARETTA GA 30005 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.