MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-15 for UNK manufactured by Medline Industries, Inc..
[42829390]
The mother reported that she was visiting her daughter in the hospital and she suffered multiple anaphylactic reactions in different areas of the facility. She was treated with her epi pen, her ventolin inhalers, steroids, oxygen and benadryl. No serious injury resulted. She thought that she experienced these reactions due to powdered latex exam gloves. Medline latex exam gloves are clearly labeled that the gloves contain natural rubber latex. The source of her reaction has not been confirmed. We have not received a sample for evaluation. There are many products in a hospital that contain latex. This account has no purchasing history for latex exam gloves in the last 5 years. Due to the reported incident and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[42829391]
It was reported that latex exam gloves in a hospital caused multiple anaphylactic reactions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00040 |
| MDR Report Key | 5581899 |
| Report Source | CONSUMER |
| Date Received | 2016-04-15 |
| Date of Report | 2016-04-15 |
| Date of Event | 2015-10-22 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2016-04-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LATEX GLOVES |
| Product Code | LYY |
| Date Received | 2016-04-15 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-15 |