ANSELL GAMMEX NON LATEX PI 816734 20685765

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for ANSELL GAMMEX NON LATEX PI 816734 20685765 manufactured by Ansell N.p. Sdn. Bhd..

Event Text Entries

[139416692] Review of the device history records indicated no abnormalities were found. Production records show that lot met the standard requirement prior to shipment release. The lot passed all the required inspections and criteria were performed according to the established procedures. No significant changes were made to the manufacturing process. Glove formulation was modified to reduce the risk of type iv allergy by eliminating certain higher risk chemicals (mainly accelerators) from the formulation and to ensure compliance with an ever more stringent regulatory environment. Returned and retained sample analysis show no abnormalities. Fit kit test that measures major allergens was performed with no detection determined. This indicates a very low probability that the gloves could have cause an allergic reaction. Chemical residue test measuring presence of accelerators and antioxidants residue show no abnormalities were found. Based on the investigation, there were no deviations nor evidence of special causes that would have led to an allergic reaction. As a result, no corrective action was rendered at this time.
Patient Sequence No: 1, Text Type: N, H10


[139416693] Incident occurred on (b)(6) 2018 in (b)(6). The customer states an employee experienced an allergic reaction while wearing ansell gammex non-latex pi surgical gloves and developed a burning/itching sensation and pink rash on her hands. The rash spread to her upper arms and then to her chest with welts. The employee was treated in the emergency room for an allergic reaction. She had elevated heart rate despite treatment and was admitted to icu due to tachycardia. She was discharged from icu after 2-3 nights.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011209798-2019-00001
MDR Report Key8438033
Date Received2019-03-20
Date of Report2019-03-20
Date of Event2018-12-26
Date Facility Aware2018-11-27
Report Date2019-03-20
Date Reported to FDA2019-03-20
Date Reported to Mfgr2018-11-28
Date Added to Maude2019-03-20
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameANSELL GAMMEX NON LATEX PI
Generic NameSURGICAL GLOVES
Product CodeKGO
Date Received2019-03-20
Model Number816734
Catalog Number20685765
Lot Number1804450404
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerANSELL N.P. SDN. BHD.
Manufacturer AddressLOT 80 KAWASAN MELAKA, 75450 MY 75450


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-03-20

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