MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-04-30 for STANDINGDANIWHEELSTAND WITH EFIX POWER ADD-ON manufactured by Davismade, Inc..
[832985]
Mother reported that child tipped over while in the wheelstand when child drove wheelst and over a dodge-ball sized ball. The ball did not deflate. Per mother's report: child had a bump on the head. Child was taken to the hosp same day. Two cat scans were done. Child had a concussion. Child was released same day.
Patient Sequence No: 1, Text Type: D, B5
[7998344]
Eval summary: in 2006, company owner and inventor of device, reviewed report of incident, determined that proper supervision was not observed at time of incident, and a precautionary measure of providing a wheel guard needed to occur. Additionally, remote stop interface (killswitch) was not in use at time of incident as instructed. As mother could not be reached several times by phone, a message was left that a wheel guard with installation instructions would be mailed as soon as available, as well as cautioned that child should be supervised at all times while utilizing the power-drive option of the unit, particularly as this child is not able to wear a helmet. On the following month: wheel guard mailed to mother. Message left on mother's voicemail requesting a service call be scheduled. On sixteen days later: mother confirms via phone that she rec'd wheel guard; had not yet installed. Service call scheduled. On two months later: service call and device visual evaluation, wheel guard installed by inventor. Mother cautioned again to maintain supervision of child at all times while utilizing power option.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1833039-2008-00001 |
| MDR Report Key | 1036565 |
| Report Source | 00 |
| Date Received | 2008-04-30 |
| Date of Report | 2008-04-23 |
| Date of Event | 2006-06-22 |
| Date Mfgr Received | 2006-06-26 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2008-05-06 |
| 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 Street | 2511 DAVISON RD |
| Manufacturer City | FLINT MI 48506 |
| Manufacturer Country | US |
| Manufacturer Postal | 48506 |
| Manufacturer Phone | 8102339706 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDINGDANIWHEELSTAND WITH EFIX POWER ADD-ON |
| Generic Name | STANDING DANI WHEELSTAND |
| Product Code | IPL |
| Date Received | 2008-04-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1004632 |
| Manufacturer | DAVISMADE, INC. |
| Manufacturer Address | 2511 DAVISON RD FLINT MI 48506 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-04-30 |