LEAD SHIELD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-21 for LEAD SHIELD * manufactured by Med Corp..

Event Text Entries

[54326] Ceiling mounted lead shield support arm cracked & separated from base. Entire unit fell to the floor causing damage to the unit as well as structural damage to the tile & concrete floor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1011335
MDR Report Key92325
Date Received1997-05-21
Date of Report1997-05-05
Date of Event1997-05-05
Date Added to Maude1997-05-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEAD SHIELD
Generic NameLEAD SHIELD
Product CodeIWQ
Date Received1997-05-21
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key91198
ManufacturerMED CORP.
Manufacturer Address101 N DAYTON PO BOX 50010 AMES IA 50010 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-05-21

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