MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-04 for BEDS BY GEORGE 3500 manufactured by Beds By George, Inc..
| Report Number | 3008830652-2019-00007 |
| MDR Report Key | 8963104 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-04 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-06-16 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-09-04 |
| 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 | MR. ADAM DAVIS |
| Manufacturer Street | 1045 N. NAPPANEE ST. |
| Manufacturer City | ELKHART IN 46514 |
| Manufacturer Country | US |
| Manufacturer Postal | 46514 |
| Manufacturer Phone | 5743332310 |
| Manufacturer G1 | BEDS BY GEORGE, INC. |
| Manufacturer Street | 109 14TH AVE S BUILDING 2 |
| Manufacturer City | MIDDLEBURY IN 46540 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46540 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEDS BY GEORGE |
| Generic Name | HAVEN |
| Product Code | OYS |
| Date Received | 2019-09-04 |
| Model Number | 3500 |
| Catalog Number | 3500 |
| Lot Number | ALEAH 082918 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEDS BY GEORGE, INC. |
| Manufacturer Address | 1045 N. NAPPANEE ST. ELKHART IN 46514 US 46514 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-04 |