MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for MCKESSON BRANDS 14-6NPNK2 manufactured by Hartalega Sdn Bhd.
| Report Number | 1451040-2019-00009 |
| MDR Report Key | 9128873 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-09-18 |
| Date Facility Aware | 2019-09-18 |
| Report Date | 2019-09-27 |
| Date Reported to Mfgr | 2019-09-27 |
| Date Added to Maude | 2019-09-27 |
| 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 NITRL 3.0 PNK SM POWDER-FREE |
| Product Code | LZA |
| Date Received | 2019-09-27 |
| Catalog Number | 14-6NPNK2 |
| Lot Number | 190609290058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARTALEGA SDN BHD |
| Manufacturer Address | C-G-9, JALAN DATARAN SD1, PJU BANDAR SRI DAMANSARA, KUALA LUMPAR 52200 MY 52200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-27 |