MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-12-07 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004707 manufactured by Independence Technology, L.l.c..
[1674253]
While speaking with the service hotline on (b)(6) 2010 regarding a different matter, the user mentioned that he had sustained an injury as a result of an event that was previously reported and documented in (b)(4), opened on (b)(6) 2010. The previously unreported injury was sustained when the user fell from the device during the earlier event. The user sustained a shoulder injury where the bicep tendon was separated from the bone. The user stated that surgery was required to repair the injury. The user also stated that he struck his head and elbow in the fall, but that neither required medical attention. When asked by company reps as to why he had not previously reported the injury, the user responded that he had been "partying with his friends" at the time of the event. The user would not provide further info regarding the event to the company. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8912356]
The user reported a previously unreported injury that occurred on (b)(6) 2010 and would not provide add'l info other than that documented in this report. The device was not made available by the user for eval and the user declined to provide further info regarding the circumstances of the original event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2010-00006 |
| MDR Report Key | 1920588 |
| Report Source | 04 |
| Date Received | 2010-12-07 |
| Date of Report | 2010-12-07 |
| Date of Event | 2010-07-28 |
| Date Mfgr Received | 2010-12-06 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2011-01-24 |
| 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 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENCE IBOT 4000 MOBILITY SYSTEM |
| Generic Name | STAIR CLIMBING WHEELCHAIR |
| Product Code | IMK |
| Date Received | 2010-12-07 |
| Model Number | IBOT |
| Catalog Number | IT004707 |
| 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, L.L.C. |
| Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-12-07 |