MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-05 for MCKESSON BRANDS 14-818 manufactured by Zibo Intco Medical Products Co. Ltd.
| Report Number | 1451040-2019-00010 |
| MDR Report Key | 9280000 |
| Date Received | 2019-11-05 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-10-16 |
| Date Facility Aware | 2019-10-17 |
| Report Date | 2019-10-28 |
| Date Reported to Mfgr | 2019-10-28 |
| Date Added to Maude | 2019-11-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON BRANDS |
| Generic Name | GLOVE, EXAM VNYL STRTCH PF |
| Product Code | LYZ |
| Date Received | 2019-11-05 |
| Catalog Number | 14-818 |
| Lot Number | CDI04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIBO INTCO MEDICAL PRODUCTS CO. LTD |
| Manufacturer Address | NO. 18 QINGTIAN ROAD QILU CHEMICAL INDUSTRY PARK ZIBO CITY, SHANDONG 255400 CH 255400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-05 |