MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-01-26 for LATEX EXAM GLOVES UNK manufactured by Allegiance Healthcare Corp..
[17766873]
The plaintiff alleges that while working as a registered nurse was exposed to antigenic natural latex proteins in the latex gloves that the plaintiff wore. The plaintiff alleges that in 1994, the plaintiff suffered an anaphylactic reaction to latex gloves, which forced the plaintiff to leave job as a registered nurse. The plaintiff further alleges that has become sensitized to latex and can no longer work as a registered nurse at any medical facility and is now subjected to increased health risks. Furthermore the plaintiff alleges that the plaintiff is subject in the future to one or more anaphylactic reactions to latex products. The plaintiff also alleges that the plaintiff has suffered substantial injury, pain and suffering and economic loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00023 |
| MDR Report Key | 313640 |
| Report Source | 04 |
| Date Received | 2001-01-26 |
| Date of Report | 2001-01-26 |
| Date of Event | 1994-06-30 |
| Date Mfgr Received | 2001-01-02 |
| Date Added to Maude | 2001-01-29 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATEX EXAM GLOVES |
| Generic Name | LATEX EXAM GLOVES |
| Product Code | LYX |
| Date Received | 2001-01-26 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 303334 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-26 |