MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-09-09 for ACORN 130 LH HINGE manufactured by Acorn Stairlifts, Inc.
[54297098]
Client filed down the edge of the rail at point of impact. Manufacturer has submitted a scar to the rail supplier.
Patient Sequence No: 1, Text Type: N, H10
[54297099]
Non user of lift was walking down the stairs and lost her balance and fell on to the stairlift. Hinged rail was not retracted per manufacturer specifications and client cut her arm on the hinge. Required 13 stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003124453-2016-00003 |
| MDR Report Key | 5939056 |
| Report Source | CONSUMER |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2016-09-09 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 130 LH HINGE |
| Generic Name | POWERED STAIRWAY CHAIRLIFT |
| Product Code | PCD |
| Date Received | 2016-09-09 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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. Required No Informationntervention | 2016-09-09 |