MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-10-07 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, Llc.
[1176720]
User's mother reported that the user was going down an incline onto a football field at the school. Caller stated that the incline was too steep, and that the foot plate caught on the ground, causing the user to fall forward out of the device onto his knees. Caller reported that the user sustained fractures to both femurs, requiring hospitalization and surgery. When asked, the caller reported that the user was not wearing the provided lap belt at the time of the event. This mdr is filed as an adverse event as there is no indication or allegation of device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8405380]
No additional information is available. The device was being used in standard function on an incline that was reportedly too steep when the foot plate caught on the ground. As the device was in standard function at the time of the event, no service code was posted. There was no reported damage to the device and no field service visit was necessary or required to return the device to functionality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00008 |
| MDR Report Key | 1502385 |
| Report Source | 00 |
| Date Received | 2009-10-07 |
| Date of Report | 2009-10-06 |
| Date of Event | 2009-09-24 |
| Date Mfgr Received | 2009-09-24 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2009-10-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL O'MEARA, DIRECTOR |
| Manufacturer Street | ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERVICES |
| Manufacturer Street | 7444 HAGGERTY ROAD |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2009-10-07 |
| Model Number | NA |
| Catalog Number | IT004051 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, LLC |
| Manufacturer Address | SOMMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-10-07 |