FDA.reportPublic FDA data

MAUDE MDR 8438033

MDR report key
8438033
Report number
3011209798-2019-00001
Event key
0
Event type
3
Date of event
2018-12-26
Date received
2019-03-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANSELL GAMMEX NON LATEX PISURGICAL GLOVESANSELL N.P. SDN. BHD.KGO816734206857651804450404* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2001. H

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.