MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-08-03 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004051 manufactured by Independence Technology, Llc.
[22051953]
This company is currently attempting to contact the user to obtain further info and investigate the reported event.
Patient Sequence No: 1, Text Type: N, H10
[22128520]
User reported a fall via telephone voice mail to the company vp of sales on 08/01/09. User states that the previously unreported event occurred on (b)(6)2009 and that he sustained 3 broken ribs and an injury to his ear. No further info is available at this time. The company is attempting to contact the user to obtain further info on the circumstances of the event. This report is being filed as an adverse event mdr at this time, pending receipt of further info. An update will be provided when further details are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003508375-2009-00005 |
| MDR Report Key | 1429378 |
| Report Source | 04 |
| Date Received | 2009-08-03 |
| Date of Report | 2009-08-03 |
| Date of Event | 2009-07-04 |
| Date Mfgr Received | 2009-08-01 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2010-08-07 |
| 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, DIR |
| Manufacturer Street | ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9087223767 |
| Manufacturer G1 | CREATIVE TECHNOLOGY SERIVCES |
| 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 | 2009-08-03 |
| 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 | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-08-03 |