RPR CONTROL CARDS 18MM CIRCLE CONTROLS 4976709

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-09-23 for RPR CONTROL CARDS 18MM CIRCLE CONTROLS 4976709 manufactured by Becton Dickinson.

Event Text Entries

[136222] User reported a potential exposure to the control/antigen mixture from the rpr control card kit. Due to user carelessness, there was exposure to the eye of control material that contains screened human plasma. User flushed eye with water and was examined by a dr. User is reported to be in good health. Because user is 6 weeks pregnant, a filling is being made as a precaution only, even though no malfunciton of the device is indicated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119779-1999-00005
MDR Report Key241959
Report Source05
Date Received1999-09-23
Date of Report1999-08-26
Date of Event1999-08-26
Date Mfgr Received1999-08-26
Device Manufacturer Date1999-04-01
Date Added to Maude1999-09-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDAVID GATES
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal21152
Manufacturer Phone4103164367
Manufacturer G1BECTON DICKINSON MICROBIOLOGY SYSTEMS
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal Code21152
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRPR CONTROL CARDS 18MM CIRCLE CONTROLS
Generic NameANTISERA, CONTROL FOR NONTREPONEMAL TESTS
Product CodeGMP
Date Received1999-09-23
Model NumberNA
Catalog Number4976709
Lot NumberD903
ID NumberNA
Device Expiration Date2000-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key234427
ManufacturerBECTON DICKINSON
Manufacturer Address7 LOVETON CIR. SPARKS MD 21152 US
Baseline Brand NameRPR CONTROL CARDS, IBMM CIRCLE CONTROLS
Baseline Generic NameANTISERA, CONTROL FOR NONTREPONEMAL TESTS
Baseline Model NoNA
Baseline Catalog No4976709
Baseline IDLOT#D903
Baseline Device FamilyDIRECT TESTING/SEROLOGY
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1999-09-23

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