INFAB PROTECTIVE WEAR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-15 for INFAB PROTECTIVE WEAR * manufactured by Infab Corp..

Event Text Entries

[144706] Exposure to radiation due to faulty lead in protective garments. Aprons and shields purchased 4/98. 3 months later lead cracked, falling to bottom of garment, leaving wearer unprotected from radiation exposure. Mfr writes to rptr: "this letter is in response to the unfortunate qc problem you experienced with a recent shipment of infab x-ray protective aprons ordered. The problem occurred as a result of our receiving a shipment of our hx lead formulation that had not been cured properly during mfr. This improper curing caused the lead vinyl to lack the normal elasticity and composite strength so that it easily tore and separated during flexing under normal use. We had never experienced this particular problem in all the 17 years we have been in the x-ray apron business so it never occurred to us to test any lead vinyl shipments against this parameter. We were only made aware of this problem after the aprons, that were produced from the 6 faulty rolls, were reported by two other end users and then from you. This all occurred in a matter of three weeks so we did not know what the problem was until the first reported faulty apron was returned to us for eval. Keep in mind we had never experienced anything like this before so we had no idea what caused the reported problem. We have since added qc controls to check for this possible "uncured" condition in the future. We stopped all other production in order to have your 14 aprons shipped to you. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1015273
MDR Report Key203369
Date Received1998-12-15
Date of Report1998-12-14
Date of Event1998-07-08
Date Added to Maude1998-12-28
Event Key0
Report Source CodeVoluntary 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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINFAB PROTECTIVE WEAR
Generic NamePROTECTIVE APRONS & DEVICES
Product CodeEAJ
Date Received1998-12-15
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key197538
ManufacturerINFAB CORP.
Manufacturer Address3651 VIA PESCADOR CAMARILLO CA 93012 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-12-15

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