UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-15 for UNK manufactured by Medline Industries, Inc..

Event Text Entries

[42829390] The mother reported that she was visiting her daughter in the hospital and she suffered multiple anaphylactic reactions in different areas of the facility. She was treated with her epi pen, her ventolin inhalers, steroids, oxygen and benadryl. No serious injury resulted. She thought that she experienced these reactions due to powdered latex exam gloves. Medline latex exam gloves are clearly labeled that the gloves contain natural rubber latex. The source of her reaction has not been confirmed. We have not received a sample for evaluation. There are many products in a hospital that contain latex. This account has no purchasing history for latex exam gloves in the last 5 years. Due to the reported incident and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10


[42829391] It was reported that latex exam gloves in a hospital caused multiple anaphylactic reactions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2016-00040
MDR Report Key5581899
Report SourceCONSUMER
Date Received2016-04-15
Date of Report2016-04-15
Date of Event2015-10-22
Date Mfgr Received2016-03-17
Date Added to Maude2016-04-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactDIANE CHRISTENSEN
Manufacturer StreetONE MEDLINE PLACE
Manufacturer CityMUNDELEIN IL 60060
Manufacturer CountryUS
Manufacturer Postal60060
Manufacturer Phone8476434747
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameLATEX GLOVES
Product CodeLYY
Date Received2016-04-15
Catalog NumberUNK
Lot NumberUNK
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-04-15

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