MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-10-19 for INDEPENDENCE IBOT 4000 MOBILITY SYSTEM IT004703 manufactured by Independence Technology, L.l.c..
[20628743]
User reports that, two (2) weeks after an upgrade to a fold flat seating design on his legrest assemblies in (b)(6) 2010, he developed sores on both ischiums ("seat bone"). User states that, in (b)(6) 2010, the sore that was on his right ischium required surgery. User states that he convalesced well and went back to using his device in (b)(6) 2010. User states that he has now developed another sore in his right ischium area that will now need surgery. User states he concludes that the legrest conversion led to the sores around both of the ischium area, with the right sore having had surgery once and probably again needing surgery. User requested that his device be converted back to the previous configuration of legrest assembly. The company is unable to fulfill that request as the parts that were removed during conversion were scrapped and replacement parts from that prior design are no longer available. This report is filed as an adverse event mdr due to the reported injury and no allegation/evidence of product malfunction. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20812512]
The service hotline attempted to work with the user on ways to adjust the legrest assemblies and requested to send field service to investigate, however, user was doubtful that the company could be of any help. User states that he deals with a seating specialist who is an expert in their profession and states this individual has already "investigated" all adjustment possibilities. In an effort to better understand the reported injury, the company obtained prior permission from the user to speak with his seating specialist. Following numerous attempts to contact the specialist, the company service mgr spoke with her on (b)(4) 2010. She stated that all she could tell us was that the user did not have the reported sores prior to the conversion. Further investigation by the company determined that an adjustment mechanism known as the "tuck linkage" may not have been adjusted properly after the conversion. There is a tuck linkage mechanism on both the left and right side of the device to help set the forward angle of each legrest, which could help relieve any pressure in the reported injury site. It was further determined that the right side tuck linkage was damaged sometime prior to the legrest conversion, which would have prevented the proper adjustment of the legrest angle, post conversion. Service to replace the right side tuck linkage was completed on (b)(4) 2010. The company suspects that inadequate/improper adjustment of the legrests post conversion may have caused or contributed to the event. The company will monitor and f/u with the user once seating/legrest adjustments have been made by the user's seating specialist to determine if those adjustments have alleviated the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003508375-2010-00004 |
| MDR Report Key | 1880009 |
| Report Source | 04 |
| Date Received | 2010-10-19 |
| Date of Report | 2010-10-19 |
| Date of Event | 2010-09-21 |
| Date Mfgr Received | 2010-09-21 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2012-04-16 |
| 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 SVS |
| Manufacturer Street | 7444 HAGGERTY RD. |
| Manufacturer City | CANTON MI 48187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48187 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2010-10-19 |
| Model Number | IBOT |
| Catalog Number | IT004703 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other; 2. Required No Informationntervention | 2010-10-19 |