GAMMEX NON-LATEX PI ORTHO 20686565

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-05-29 for GAMMEX NON-LATEX PI ORTHO 20686565 manufactured by Ansell Lanka (pvt) Limited.

Event Text Entries

[17294566] An mdr is being filed after user facility informed that the door, who has a known allergy to polyisoprene, developed a severe systemic allergic reaction after use of polyisoprene glove, gammex non-latex pi ortho. End user claimed that distributor sent the wrong replacement product.
Patient Sequence No: 1, Text Type: D, B5


[17622069] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1019632-2014-00009
MDR Report Key3879616
Report Source06,08
Date Received2014-05-29
Date of Report2014-05-29
Date of Event2014-05-28
Date Facility Aware2014-05-28
Report Date2014-05-29
Date Reported to FDA2014-05-29
Date Reported to Mfgr2014-05-29
Date Mfgr Received2014-05-28
Date Added to Maude2014-06-19
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTAMMY MCGRIFF
Manufacturer Street1635 INDUSTRIAL RD.
Manufacturer CityDOTHAN AL 36303
Manufacturer CountryUS
Manufacturer Postal36303
Manufacturer Phone3346152566
Manufacturer G1ANSELL LANKA (PVT) LIMITED
Manufacturer Street1635 INDUSTRIAL RD.
Manufacturer CityDOTHAN AL 36303
Manufacturer CountryUS
Manufacturer Postal Code36303
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGAMMEX NON-LATEX PI ORTHO
Generic NamePOWDER-FREE NON-NATURAL RUBBER LATEX
Product CodeOPA
Date Received2014-05-29
Catalog Number20686565
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerANSELL LANKA (PVT) LIMITED
Manufacturer AddressBIYAGAMA CE


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-05-29

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