LATEX GLOVES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for LATEX GLOVES manufactured by Eudermic.

Event Text Entries

[29924644] I visited (b)(6) 2015 with my daughter. She was in pain from a previous car wreck/multiple ovarian cysts. The staff was notified that i am type i latex allergic and that she had contact latex allergy. We were still put in a room containing latex gloves. Within minutes i went into anaphylaxis and administered epinephrine. I used my rescue inhaler and took 50mg of benadryl in front of the attending physician. No check was performed. After my epi, the reaction quickly subsided for a few minutes. My daughter was taken to radiology, and i was left alone in the room. The reaction started again, and another epipen and 50mgs of benadryl were needed. The epi pens were left out for the doctor in case i became unconscious. The doctor never asked how i was. He looked at the epi pens but made no comment. I emailed the hospital administration and ceo the following day and was told latex had been removed from all the rooms. Last night, (b)(6) 2015, i went back to (b)(6) with anaphylaxis from latex exposure (airborne). I was in room 4, and required 2 epi pens, benadryl, steroids, and oxygen. The longer i stayed in the room the worse i felt. My husband found a bin of latex gloves on the counter. These are my most recent experiences at this hospital, but definitely not all. Each time i have presented with anaphylaxis from latex exposure i have been placed in rooms with latex. At this pint i feel my rights under (b)(4) have been violated, and that i am a victim of medical negligence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5057542
MDR Report Key5187623
Date Received2015-10-23
Date of Report2015-10-23
Date of Event2015-10-22
Date Added to Maude2015-10-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLATEX GLOVES
Generic NameLATEX GLOVES
Product CodeLYY
Date Received2015-10-23
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEUDERMIC


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2015-10-23

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