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 2017-12-12 for LATEX GLOVES manufactured by Unk.

Event Text Entries

[95002020] I am latex allergic stage iv per dr w cain diagnose, since 2006. I have never filed a complaint to the gov in regards to latex exposure in a medical setting. Please note through out the years i have had many incidents of exposures to latex just because the medical staff was not properly educated. Even though most places no longer use latex gloves there are still few out there. And a latex allergy is more than just wearing a pair of latex gloves. There needs to be across the usa, specific guide lines for pts allergic to latex. Even if that place does not use latex gloves. (b)(6) 2017, i had an mri appt, told them when i called i was allergic to latex, told the front desk told the xray tech. They all acknowledge this. I get in the mri machine, the xray tech put headphones on my head/ears, and started to get very hot, funny taste in my mouth, ears burning and itching. This is multi allergic reaction to latex. I told the man to get me out of the mri by that i was short of breath. He did and he could not understand at that time what was wrong with me. I asked him "do you have latex in here. " he pointed to the latex glove box next to the non latex glove box. He was not using them on me so he thought i guess it was ok. No latex gloves, needs to be in the room are used prior to a pt coming in the room. I had to exit the room quickly, get dressed rescheduled and left. I had to do my pro air inhaler. Benadryl, and prednisone. I did not have any n-95 facemask on. I did not think i would need it. I was the first pt of the day and i had told them i was latex allergic. The following monday, i went back with a mask on, went to another room had my test done without incident. I do not fault the man that did my mri, i fault the lack of latex allergy education in the different medical centers that are off campus. I strongly feel i should not have to teach every time i go to a medical place about latex allergy. Date the person first started taking or using the product: (b)(6) 2017. "did the problem stop after the person reduced the dose or stopped taking or using the product: yes. " (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073950
MDR Report Key7112234
Date Received2017-12-12
Date of Report2017-12-11
Date of Event2017-10-18
Date Added to Maude2017-12-13
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 Received2017-12-12
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Deathisabilit 2017-12-12

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