MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-10-30 for INTEGRATED POWER SUPPLY US N/A 15072-000-0010 manufactured by Q Core Medical Ltd..
| Report Number | 3010293992-2019-00095 |
| MDR Report Key | 9254256 |
| Report Source | FOREIGN |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-01 |
| Date Facility Aware | 2019-10-01 |
| Date Added to Maude | 2019-10-30 |
| 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 | MS. JUDITH ANTLER |
| Manufacturer Street | YAD HARUZIM ST. 29 |
| Manufacturer City | NETANYA, 4250529 |
| Manufacturer Country | IS |
| Manufacturer Postal | 4250529 |
| Manufacturer G1 | Q CORE MEDICAL LTD. |
| Manufacturer Street | YAD HARUZIM ST. 29 |
| Manufacturer City | NETANYA, 4250529 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 4250529 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRATED POWER SUPPLY US |
| Generic Name | POWER SUPPLY |
| Product Code | MRZ |
| Date Received | 2019-10-30 |
| Model Number | N/A |
| Catalog Number | 15072-000-0010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | Q CORE MEDICAL LTD. |
| Manufacturer Address | YAD HARUZIM ST. 29 NETANYA, 4250529 IS 4250529 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-30 |