LATEX TOE SHIELD UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-03 for LATEX TOE SHIELD UNK manufactured by Liquid Rubber Appliance Laboratories, Inc..

Event Text Entries

[20192228] Podiatrist reports that 3 or 4 of his pts in the last 1 1/2 yrs have had allergic reactions including localized itching, redness, and swelling after using latex toe shields. Dr's concern is that this may sensitize pts to latex and later head to anaphylactic reactions upon exposure to other latex products.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1010864
MDR Report Key72457
Date Received1997-03-03
Date of Report1997-03-03
Date Added to Maude1997-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLATEX TOE SHIELD
Generic NameLATEX TOE SHIELD
Product CodeMNE
Date Received1997-03-03
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key72331
ManufacturerLIQUID RUBBER APPLIANCE LABORATORIES, INC.
Manufacturer Address45 VALLEY WAY WEST ORANGE NJ 07052 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-03-03

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