ILLUSION GLOVE PF LATEX GRAPE 1032711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-06-16 for ILLUSION GLOVE PF LATEX GRAPE 1032711 manufactured by Purnabia Adventa Health.

Event Text Entries

[2094381] The customer alleges that a staff member, female, (b)(6), who has a known allergy (hypersensitivity) to latex, developed swelling of the throat, and difficulty breathing (dyspnea). She did not wear the gloves but other staff members were wearing these gloves around her. She took a benadryl before going to the hospital. The hospital did administer a medication but not through an iv. She was monitored and released.
Patient Sequence No: 1, Text Type: D, B5


[9189219] Additional catalog #: 1032712. Additional lot #: 1010348.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2411236-2011-00002
MDR Report Key2153078
Report Source99
Date Received2011-06-16
Date of Report2011-05-19
Date of Event2011-05-19
Date Facility Aware2011-05-19
Report Date2011-06-16
Date Reported to FDA2011-06-16
Date Reported to Mfgr2011-06-16
Date Added to Maude2011-11-02
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameILLUSION GLOVE PF LATEX GRAPE
Generic NameLATEX EXAMINATION GLOVE GRAPE
Product CodeLYY
Date Received2011-06-16
Returned To Mfg2011-06-06
Catalog Number1032711
Lot Number1010349
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPURNABIA ADVENTA HEALTH
Manufacturer AddressKLUANG MY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-06-16

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