LEAD APRON THYROID SHIELD UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-28 for LEAD APRON THYROID SHIELD UNK manufactured by Burlington Medical Supplies.

Event Text Entries

[69350] Thyroid shield is contaminated. The geiger meter gave a reading of. 01 mr/hr of the background. The shield was. 7 mr/hr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1011774
MDR Report Key108475
Date Received1997-07-28
Date of Report1997-07-28
Date of Event1997-07-17
Date Added to Maude1997-07-30
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 Sequence Number: 1

Brand NameLEAD APRON THYROID SHIELD
Generic NameTHYROID SHIELD
Product CodeEAJ
Date Received1997-07-28
Returned To Mfg1997-07-18
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key106613
ManufacturerBURLINGTON MEDICAL SUPPLIES
Manufacturer AddressP.O. BOX 1388 32 STEVENS ST. HAVERHILL MA 01830 US

Device Sequence Number: 2

Brand NameLEAD APRON THYROID SHIELD
Generic NameTHYROID SHIELD
Product CodeKPY
Date Received1997-07-28
Returned To Mfg1997-07-18
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No2
Device Event Key106614
ManufacturerBURLINGTON MEDICAL SUPPLIES
Manufacturer AddressP.O. BOX 1388 32 STEVENS ST HAVERHILL MA 01830 US

Patients

Patient NumberTreatmentOutcomeDate
10 1997-07-28
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