MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-25 for THE BELMONT HYPERTHERMIA PUMP 902-00001 manufactured by Belmont Medical Technologies.
| Report Number | 1219702-2020-00032 |
| MDR Report Key | 9880565 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2020-03-25 |
| 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. SABRINA BELLADUE |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 3307637 |
| Manufacturer G1 | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Street | 780 BOSTON ROAD |
| Manufacturer City | BILLERICA, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE BELMONT HYPERTHERMIA PUMP |
| Generic Name | THERMAL INFUSION FLUID WARMER |
| Product Code | LGZ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-06 |
| Model Number | HYPERTHERMIA PUMP |
| Catalog Number | 902-00001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELMONT MEDICAL TECHNOLOGIES |
| Manufacturer Address | 780 BOSTON ROAD BILLERICA, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |