MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-03-03 for RT300-SLSA FA104581 manufactured by Restorative Therapies Inc..
[1334293]
Pt has c1/c2 (b) (6) a spinal cord injury. Pt experienced wrist fracture probably while "one arm" fes cycling using rt300 fes arm ergometer. Pt's mother advises that no one recalls any falls or getting pt's arm stuck or twisted. Mother recalled that at the last fes cycling session, her daughter asked for a hug while cycling and the mother had placed her arms around her neck and pulled toward her and thought there could possibly have been twisting of the wrist. The next day, mother noticed a bump on the wrist and the following day they took her to the orthopedist.
Patient Sequence No: 1, Text Type: D, B5
[8516961]
We contacted the prescribing clinic and determined that they have seen a total of two instances of pediatric buckle wrist fracture probably related to fes arm cycling. The clinic conducted a meeting to discuss these two cases and advised us that the buckle wrist fractures were due to twisting of the pt while cycling. Together we prepared the following add'l caution for the product user guide: add'l cautions for upper extremity ergometry with children. Torus fractures, or buckle fractures, are extremely common injuries seen in children. Because children have softer bones, one side of the bone may buckle upon itself without disrupting the other side; this is also known as an incomplete fracture. Torus fractures have been reported in children during upper extremity ergometry. To reduce the chance of wrist injury: ensure that the wrist is well supported during upper extremity ergometry. Ensure that the hand, wrist and arm adaptations recommended by your clinician are always used. Ensure that the child remain seated straight on towards the ergometer and avoid twisting motion of the forearm and wrist. The clinic has advised that this issue relates to younger children, under 14 years of age. Restorative therapies will contact pediatric clinics that have the rt300-slsa system and advise them of this new caution. We will also contact the family of under 10 year old pts who fes arm cycle and advise them of the caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004733458-2010-00001 |
| MDR Report Key | 1623559 |
| Report Source | 04 |
| Date Received | 2010-03-03 |
| Date of Report | 2010-03-03 |
| Date of Event | 2010-02-10 |
| Date Mfgr Received | 2010-02-10 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-03-10 |
| 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 Street | 907 SOUTH LAKEWOOD AVE. |
| Manufacturer City | BALTIMORE MD 21224 |
| Manufacturer Country | US |
| Manufacturer Postal | 21224 |
| Manufacturer Phone | 8006099166 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT300-SLSA |
| Generic Name | FES CYCLE ERGOMETER |
| Product Code | GZI |
| Date Received | 2010-03-03 |
| Model Number | FA104581 |
| 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 | RESTORATIVE THERAPIES INC. |
| Manufacturer Address | BALTIMORE MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-03 |