MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2001-03-09 for UNK manufactured by Ansell.
[224525]
The legal complaint states that the individual became allergic to latex as a result of the exposure to and wearing of latex medical gloves used in the performance of their "hib" duties.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520348-2001-00025 |
| MDR Report Key | 319831 |
| Report Source | 00,04 |
| Date Received | 2001-03-09 |
| Date of Report | 2001-03-09 |
| Date of Event | 1997-10-01 |
| Date Reported to FDA | 2001-03-09 |
| Date Reported to Mfgr | 2001-03-05 |
| Date Mfgr Received | 2001-03-05 |
| Date Added to Maude | 2001-03-14 |
| 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 | 3 |
| Manufacturer Contact | JAMES CHATTERTON |
| Manufacturer Street | 1875 HARSH AVENEU SE |
| Manufacturer City | MASSILLON OH 44646 |
| Manufacturer Country | US |
| Manufacturer Postal | 44646 |
| Manufacturer Phone | 3308332811 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | LATEX MEDICAL GLOVES |
| Product Code | LYX |
| Date Received | 2001-03-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 309362 |
| Manufacturer | ANSELL |
| Manufacturer Address | 1875 HARSH AVENUE SE MASSILLON OH 44646 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-03-09 |