MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-04 for BEDS BY GEORGE 2500 manufactured by Beds By George.
| Report Number | 3008830652-2019-00002 |
| MDR Report Key | 8960136 |
| Report Source | CONSUMER |
| Date Received | 2019-09-04 |
| Date of Report | 2019-09-03 |
| Date of Event | 2019-07-10 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2019-04-10 |
| 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 | CALEB TIPTON |
| Manufacturer Street | 1045 N. NAPPANEE STREET |
| Manufacturer City | ELKHART IN 46514 |
| Manufacturer Country | US |
| Manufacturer Postal | 46514 |
| Manufacturer Phone | 5743332310 |
| Manufacturer G1 | BEDS BY GEORGE |
| Manufacturer Street | 1045 N. NAPPANEE STREET |
| Manufacturer City | ELKHART IN 46514 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46514 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEDS BY GEORGE |
| Generic Name | STD-SIDE, FULL SIZE, MANUAL HEAD ADJUST SAFETY BED |
| Product Code | FNJ |
| Date Received | 2019-09-04 |
| Model Number | 2500 |
| Catalog Number | 2500 |
| Lot Number | HAUPT 121318-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEDS BY GEORGE |
| Manufacturer Address | 1045 N. NAPPANEE STREET ELKHART IN 46514 US 46514 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |