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.
[136981291]
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
[136981292]
Plaintiff alleges that from approximately 1994 to 2018, she was exposed to asbestos through her use of triflex gloves while working as a pathologist at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00273 |
| MDR Report Key | 8364874 |
| 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 | 3 |
| 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 |