MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-24 for UNKNOWN PRODUCT-MED manufactured by Cardinal Health (thailand) 222 Limited.
[136982781]
Based on limited information provided at this time and no product code or product sample, we are unable to provide any further detail related to this report.
Patient Sequence No: 1, Text Type: N, H10
[136982782]
Plaintiff alleges that from approximately 1976 to 2006, in the course of her work as a nurse for various employers in (b)(6), plaintiff (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, causing her to develop mesothelioma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00274 |
| MDR Report Key | 8364893 |
| Date Received | 2019-02-24 |
| Date of Report | 2019-02-23 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICIA TUCKER |
| Manufacturer Street | 3651 BIRCHWOOD DRIVE |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Street | 7/111 MOO 4 HIGHWAY #331, MABY |
| Manufacturer City | RAYONG 21140 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 21140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN PRODUCT-MED |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-02-24 |
| Model Number | UNKNOWN PRODUCT-MED |
| Catalog Number | UNKNOWN PRODUCT-MED |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Address | 7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-24 |