MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for LATEX GLOVES manufactured by Unk.
[174324961]
I have a severe latex allergy. I have had anaphylaxis in the past. Please see (b)(6) petition with over 100 signatures. I carry 2 epi pens and would like latex gloves banned from all food services in (b)(6). Many states have adopted due to severe allergies. I would also like powered latex gloves from being manufactured due to severity of airborne allergy of latex. (b)(6). Thank you, (b)(6). Please let me know if this is being addressed. Thanks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092099 |
| MDR Report Key | 9564473 |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-04 |
| Date Added to Maude | 2020-01-08 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX GLOVES |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2020-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-01-07 |