MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-30 for LATEX GLOVES manufactured by .
[18571786]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036441 |
| MDR Report Key | 3851273 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-29 |
| Date of Event | 2014-05-17 |
| Date Added to Maude | 2014-06-06 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX GLOVES |
| Generic Name | LATEX |
| Product Code | LYY |
| Date Received | 2014-05-30 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2014-05-30 |