ALIMED, INC. * X91-202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-26 for ALIMED, INC. * X91-202 manufactured by B.t. Medical.

Event Text Entries

[92113] On 7/10/97 - notice of alert from u. S. Regulatory commission re: the possibility of shielding products containing lead to be contaminated with small amounts of naturally occurring radioactive material. The hosp. Tested two aprons and found them to have low level radiation contamination. The aprons were returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number122313
MDR Report Key122313
Date Received1997-09-26
Date of Report1997-07-29
Date of Event1997-07-23
Report Date1997-07-29
Date Reported to FDA1997-07-30
Date Reported to Mfgr1997-07-30
Date Added to Maude1997-09-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALIMED, INC.
Generic NameLEAD APRONS (2)
Product CodeEAJ
Date Received1997-09-26
Returned To Mfg1997-07-23
Model Number*
Catalog NumberX91-202
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age5 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key119794
ManufacturerB.T. MEDICAL
Manufacturer Address2ND & DEPOT ST. BRIDGEPORT PA 19405 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1997-09-26

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