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 Number: MW1040134
• MDR Report Key: 755500
• Date Received: 2006-08-22
• Date of Report: 2006-07-16
• Date of Event: 2006-06-26
• Date Added to Maude: 2006-08-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDIVEN
• Generic Name: SUPPORT HOSE
• Product Code: DWL
• Date Received: 2006-08-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 743334
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other	2006-08-22