MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-25 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004709 manufactured by Independence Technology, Llc..
[19528488]
User reported that he sustained fractures to his right side tibia and fibula when his foot slipped off the foot plate and he caught it and his leg under the device while driving out a doorway into his back yard in standard function. User stated that he had increased (widened) the distance between the device foot plates in 2009, and that while driving out into his back yard, his food slipped off the foot plate and got caught under the device. User stated that his leg was also pulled under device as the device was moving forward. User was transported to er by ambulance, but reported that surgery was not required. Fractured bones were placed in a cast for recovery. Note: the user stated that the event occurred in 2009, but was not reported to the company by the user until he called for another reason the following month.
Patient Sequence No: 1, Text Type: D, B5
[19670307]
The user reported no damage to the device as a result of the reported event. No evaluation was conducted, as there was no reported device malfunction, and the device was not made available to the company for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2009-00009 |
| MDR Report Key | 1548753 |
| Report Source | 04 |
| Date Received | 2009-11-25 |
| Date of Report | 2009-11-24 |
| Date of Event | 2009-10-30 |
| Date Mfgr Received | 2009-11-23 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2009-12-04 |
| 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 RD. |
| 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 | 2009-11-25 |
| Model Number | NA |
| Catalog Number | IT004709 |
| 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 | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-11-25 |