MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-13 for REMINGTON MEDICAL manufactured by Remington Medical.
| Report Number | 1056553-2019-00002 |
| MDR Report Key | 9319570 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-21 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2019-11-13 |
| 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 | MATT BROWN |
| Manufacturer Street | 6830 MEADOWRIDGE COURT |
| Manufacturer City | ALPHARETTA GA 30005 |
| Manufacturer Country | US |
| Manufacturer Postal | 30005 |
| Manufacturer Phone | 4707191121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REMINGTON MEDICAL |
| Generic Name | DISPOSABLE ADAPTER |
| Product Code | DSA |
| Date Received | 2019-11-13 |
| Lot Number | 1907911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMINGTON MEDICAL |
| Manufacturer Address | ALPHARETTA GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-13 |