UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-25 for UNK * manufactured by Unk.

Event Text Entries

[22081842] In response to the letter from dist dated june 13, 1997 informing us of an up-coming fda notice of lead powder contaminated with radiographic source emitting low levels of radiation used in aprons and shields, all aprons and shields purchased after october 1, 1996 were immediately inspected with a geiger counter. Three aprons purchased after october 1, 1996 were located and tested and one was found to be contaminated. As a precaution, in addition to annual testing, all aprons and shields were checked for low level contamination and lead defects. As a result of the immediate inspection, only one apron was found to be contaminated. This apron was removed and given to dr. To be disposed of properly. The annual inspection of the aprons, gloves, thyroid shields and gonadal shield from the following areas: gi lab, acu, outpt radiology, inpt radiology, er, dental lab, cvc, shic, imc, cath lab, and imaging was completed. All the aprons and thyroid shields were checked with a geiger counter. The center will be checked soon. All aprons and thyroid shields located were checked with fluoro for defects in the lead. One from radiology and one from were found to be defective, removed and discarded. All findings and problems will be brought to the attention of the appropriate area by letter. All gloves located were checked radiographically and some small cracks were noted. They were not felt to be significant enough to pull them from use. The radiographs will be checked with the physicist for confirmation. The figleaf and small gonadal shields were checked visually for defects and none were found.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1011973
MDR Report Key116138
Date Received1997-08-25
Date of Report1997-08-10
Date Added to Maude1997-09-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRADIOLOGIC TECHNOLOGIST
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 NameUNK
Generic NameLEAD APRON
Product CodeEAJ
Date Received1997-08-25
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key113953
ManufacturerUNK
Manufacturer AddressUNK UNK *

Device Sequence Number: 2

Brand NameUNK
Generic NameRADIATION SAFETY GLOVE
Product CodeKPY
Date Received1997-08-25
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key113955
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
10 1997-08-25

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