AMNISURE ROM TEST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-27 for AMNISURE ROM TEST * manufactured by Amnisure International.

Event Text Entries

[2299738] A patient was suspected of spontaneous rupture of membranes. The test result was negative. The patient came back six hours later febrile and positive chorioamnionitis. There are two possible lot numbers and both are reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2326060
MDR Report Key2326060
Date Received2011-10-27
Date of Report2011-10-13
Date of Event2011-09-28
Report Date2011-10-13
Date Reported to FDA2011-10-27
Date Added to Maude2011-11-07
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 Sequence Number: 1

Brand NameAMNISURE ROM TEST
Generic NameNON-INSTRUMENTED QUALITATIVE IMMUNOCHROMATOGRAPHIC
Product CodeNQM
Date Received2011-10-27
Model Number*
Catalog Number*
Lot NumberA1003
ID Number*
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerAMNISURE INTERNATIONAL
Manufacturer Address24 SCHOOL STREET 6TH FLOOR BOSTON MA 02108 US 02108

Device Sequence Number: 2

Brand NameAMNISURE ROM TEST
Generic NameNON-INSTRUMENTED QUALITATIVE IMMUNOCHROMATOGRAPHIC
Product CodeNQM
Date Received2011-10-27
Model Number*
Catalog Number*
Lot Number80005
ID Number*
Device AvailabilityN
Device Sequence No2
Device Event Key0
ManufacturerAMNISURE INTERNATIONAL
Manufacturer Address24 SCHOOL STREET 6TH FLOOR BOSTON MA 02108 US 02108

Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-27
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