STREPTEX LATEX GRP, A ZL51

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-16 for STREPTEX LATEX GRP, A ZL51 manufactured by Murex Corp..

Event Text Entries

[17111125] Quality control for product showed agglutination with strep a (positive control), strep b (negative control), and sterile distilled water. The product was autoagglutinating.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1001093
MDR Report Key12048
Date Received1994-03-16
Date of Report1994-03-10
Date of Event1994-03-09
Date Added to Maude1994-03-17
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 Details

Brand NameSTREPTEX LATEX GRP, A
Product CodeGTY
Date Received1994-03-16
Catalog NumberZL51
Lot NumberK182710
Device Expiration Date1994-12-28
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key12048
ManufacturerMUREX CORP.
Manufacturer AddressNORCROSS GA 300711542 US


Patients

Patient NumberTreatmentOutcomeDate
10 1994-03-16

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