MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-09-23 for ACORN 180 manufactured by Acorn Stairlifts, Inc..
[55561349]
We have received conflicting information regarding whether or not client was using the lift at time of incident. Further investigation required.
Patient Sequence No: 1, Text Type: N, H10
[55561350]
Client fell when exiting the lift at the top of the stairs. Broken collarbone. Received conflicting information later suggesting lift not being used at time of fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2016-00004 |
| MDR Report Key | 5975051 |
| Report Source | CONSUMER |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2015-01-07 |
| Date Added to Maude | 2016-09-23 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TRACY BERO |
| Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
| Manufacturer City | ORLANDO FL 32809 |
| Manufacturer Country | US |
| Manufacturer Postal | 32809 |
| Manufacturer Phone | 4076500216 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACORN 180 |
| Generic Name | STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2016-09-23 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-09-23 |