MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for ACORN 180 US LH manufactured by Acorn Stairlifts, Inc..
| Report Number | 3003124453-2019-00007 |
| MDR Report Key | 8952448 |
| Date Received | 2019-08-30 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-07-21 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2019-08-30 |
| 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 | MR. SHAWN HERBST |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 8885630410 |
| Manufacturer G1 | ACORN STAIRLIFTS, INC. |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACORN 180 US LH |
| Generic Name | POWER STAIRWAY CHAIR LIFT |
| Product Code | PCD |
| Date Received | 2019-08-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACORN STAIRLIFTS, INC. |
| Manufacturer Address | 7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-08-30 |