MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-24 for UNKNOWN OPERATING ROOM UNKNOWN GLOVES manufactured by Covidien.
[136983276]
If additional information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[136983277]
Plaintiff alleges that from approximately 1976 to 2006, in the course of her work as a nurse for various employers in (b)(6), regularly and frequently used latex gloves manufactured, distributed, sold and supplied by the defendants. Upon information and belief, the use of these latex gloves exposed plaintiff (b)(6) to respirable asbestos fibers from asbestos-containing talc and/or talcum powder sold and/or distributed by defendants, proximately causing her to develop mesothelioma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2019-08292 |
| MDR Report Key | 8364948 |
| Date Received | 2019-02-24 |
| Date of Report | 2019-02-24 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-24 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN OPERATING ROOM |
| Generic Name | POWDERED LATEX PATIENT EXAMINATION GLOVE |
| Product Code | OPE |
| Date Received | 2019-02-24 |
| Model Number | UNKNOWN GLOVES |
| Catalog Number | UNKNOWN GLOVES |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-02-24 |