MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-03-03 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004061 manufactured by Independence Technology, L.l.c..
[18829753]
During an unrelated conversation with the co svc mgr in 2008, a user reported an event that occurred in 2006. User reported that he was brewing beer and "rushing a bit to get things done". User did not notice that a wheel was tangled in a cooling line for a 6 galloon turkey fryer being used to boil the beer, and when moving the device, the just boiled contents of the fryer was spilled over him. User stated that he was hospitalized for a period of time, but did not provide any further details, the exact date of the event is not known, but has been entered as two days later, for reporting purposes. There is no indication of any device malfunction associated with this event, however the co has elected to file a medical device report after becoming aware of the user's injury and hospitalization. This report corresponds to independence technology complaint.
Patient Sequence No: 1, Text Type: D, B5
[19006606]
The user reported the event to the co in 2008, although the event occurred in 2006. There is no indication of device malfunction, rather, statements from the user suggest that the event occurred as a result of the user not being fully cognizant of his surroundings. The device was not returned, or made available for eval. No further action will be taken by the co.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2008-00001 |
| MDR Report Key | 1007973 |
| Report Source | 04 |
| Date Received | 2008-03-03 |
| Date of Report | 2008-02-29 |
| Date of Event | 2006-09-03 |
| Date Mfgr Received | 2008-02-13 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2008-09-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL O'MEARA, DIR |
| Manufacturer Street | 45 TECHNOLOGY DR. |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084122200 |
| 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 | 2008-03-03 |
| Model Number | NA |
| Catalog Number | IT004061 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1006332 |
| Manufacturer | INDEPENDENCE TECHNOLOGY, L.L.C. |
| Manufacturer Address | 45 TECHNOLOGY DR. WARREN NJ 07059 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-03-03 |