MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-06-11 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004700 manufactured by Independence Technology, L.l.c..
[16604379]
The mfr has no evidence that the reported rash is associated with the use of the device as the device armrests do not contain latex, to which the user has a stated allergy. No further info is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[16677242]
User required about the composition of the armrest material on the device. The user stated that he has a latex allergy and was getting rashes on his arms. The user stated that the armrests were not damaged, worn or cracked. The user did not allege that the device caused the reported rash- just inquired about the material. The chu noted that since date of original delivery in (b)(6) 2007, the call history for this device/ user did not show any other complaints reported for rash or allergic reaction. The company reconfirmed with the armrest mfr that latex is not used in the mfr of any of its products. Company records also confirm that biocompatibility testing performed during device product design was satisfactory and did not indicate any biocompatibility issues with the chosen materials. There have been no similar reports from any other source. The company has followed up with the user regarding the findings. Although it is believed that the device is not the source of the reported event, the company has elected to file an adverse event report due to the reported rash. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003508375-2012-00002 |
| MDR Report Key | 2623684 |
| Report Source | 04 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-11 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2012-05-25 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2012-08-06 |
| 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 | SOMMERVILLE 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 |
| 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 | 2012-06-11 |
| Model Number | IBOT |
| Catalog Number | IT004700 |
| Lot Number | NOT APPLICABLE |
| ID Number | NOT APPLICABLE |
| 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 | SOMMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-11 |