MAUDE Adverse Event Report: LATEX GLOVES

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 05/17/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 my boyfriend and i were eating at (b)(6) when i had an anaphylactic reaction.Initially, i was eating a stuffed mushroom when my throat felt tight.The waitress took it back and when i questioned her about how it was cooked, she said latex gloves are worn in the kitchen.I asked for a salad to be made separately without gloves.I began to eat that and my throat started closing tighter and i had hives on my neck and chest.I took benadryl and did my epi pen while 911 was called.I have a severe latex allergy.

• Brand Name: LATEX GLOVES
• Type of Device: LATEX
• MDR Report Key: 3851273
• MDR Text Key: 18571786
• Report Number: MW5036441
• Device Sequence Number: 1
• Product Code: LYY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31 YR