MEDIVEN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-22 for MEDIVEN * manufactured by *.

Event Text Entries

[15680506] I bought some "latex free" support thigh high hose. I was told that they were latex free. Immediately after putting the hose on i started to react to them. I took them off and took benadryl 3 times. Upon arriving at work i had trouble talking and breathing. I was having an anaphylactic reaction. I ended up at the emergency department at the hospital i work at then was transported to an adult hospital and was admitted. I will be on medication for 6 months. Medium therapeutic support stockings. They were made of spandex.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1040134
MDR Report Key755500
Date Received2006-08-22
Date of Report2006-07-16
Date of Event2006-06-26
Date Added to Maude2006-08-30
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 Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDIVEN
Generic NameSUPPORT HOSE
Product CodeDWL
Date Received2006-08-22
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key743334
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other 2006-08-22

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