CUR4045R

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 2018-05-31 for CUR4045R manufactured by Medline Industries Inc..

Event Text Entries

[109709064] It was reported that the end-user experienced a reaction of hives, tongue and facial swelling, and redness to her face after using the gloves for approximately 20-30 minutes. The end-user states that she felt as though her "throat was closing. " reportedly, the end-user went to a hospital emergency department (ed) where she received an unidentified "steroid shot," famotidine, and benadryl. No diagnostic testing reported. She was not admitted to the hospital after her ed visit. The end-user reported that she has been taking benadryl every 4 hours since her ed visit. The box of gloves was reportedly discarded. There is no sample available to be returned to the manufacturer for evaluation. No additional product information provided. Since her ed visit, approximately 1 week ago, the end-user reports improvement of reported symptoms. Due to the reported incident, the need for medical intervention, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[109709065] It was reported that the end-user experienced a reaction of hives, tongue and facial swelling, and redness to her face after using the gloves for approximately 20-30 minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2018-00049
MDR Report Key7558152
Report SourceCONSUMER
Date Received2018-05-31
Date of Report2018-05-31
Date of Event2018-05-25
Date Mfgr Received2018-05-29
Date Added to Maude2018-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 600932753
Manufacturer CountryUS
Manufacturer Postal600932753
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameGLOVE,EXAM,NITRILE,PF,LF,40CT,OSFM
Product CodeLZA
Date Received2018-05-31
Catalog NumberCUR4045R
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2018-05-31

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