MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-02-12 for BRUNO ELECTRA-RICE II SRE-1550 manufactured by Bruno Independent Living Aids.
[2141393]
Patient sustained serious injuries when the arm of her electra-ride ii straight-rail stairlift broke away as she was being carried up the stairs at her residence, causing her to fall down the stairs.
Patient Sequence No: 1, Text Type: D, B5
[9207122]
As of the date of this submission, no evaluation has been done due to possible litigation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2131358-2007-00011 |
MDR Report Key | 2171401 |
Report Source | 04 |
Date Received | 2007-02-12 |
Date of Report | 2007-01-11 |
Date of Event | 2006-12-11 |
Date Mfgr Received | 2007-01-11 |
Device Manufacturer Date | 2006-05-01 |
Date Added to Maude | 2011-07-26 |
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 | ATTORNEY |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | TERRY ANDRUS |
Manufacturer Street | 1780 EXECUTIVE DR. P.O. BOX 84 |
Manufacturer City | OCONOMOWOC WI 53066 |
Manufacturer Country | US |
Manufacturer Postal | 53066 |
Manufacturer Phone | 2625674990 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BRUNO ELECTRA-RICE II |
Generic Name | INCLINED STAIRWAY ELEVATOR |
Product Code | ILK |
Date Received | 2007-02-12 |
Model Number | SRE-1550 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BRUNO INDEPENDENT LIVING AIDS |
Manufacturer Address | OCONOMOWOC WI US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2007-02-12 |