MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-17 for MDS808210ARE manufactured by Medline Industries Inc..
[186542155]
It was reported by the customer's daughter, that her father, transferred her mother, out of the car and into the transport chair which was sitting on the driveway. Customer stated that the driveway has a slight incline, however after her father put the brakes on the transport chair and turned around to get something else out of the car the breaks did not hold and the chair started to slip down the driveway. The father reportedly jumped toward the transport chair to grab the chair before it rolled down the driveway and he fell to the ground. The father was able to grab the bottom of the chair to prevent the chair from rolling, however he was not able to get back up from the ground without assistance from others. The father went to his personal care doctor for follow up and reportedly had x-rays performed at his personal care doctor's office. The customer reported that her father reportedly fractured an unknown number of ribs on his left side. The customer does not know how many ribs were fractured but stated there was no medical intervention required or other injury noted. The customer stated that there was no incident that occurred with her mother. The mother remained in the chair without incident or injury. The chair is available and has been requested to be returned for evaluation. Due to the reported incident of the customer's father experiencing fractured ribs and in an abundance of caution, this medwatch is being filed. No additional information is available. The device was not returned to the manufacturer for evaluation. The customer reported issue was not confirmed. No additional information is available. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186542156]
Reportedly, per the end user, the brakes on the transport chair were not locking, resulting in the customer falling and fracturing an unknown number of ribs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00008 |
| MDR Report Key | 9716793 |
| Report Source | CONSUMER |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 6434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSPORT CHAIR,ALUM, BASIC,12" WHL,RED |
| Product Code | INM |
| Date Received | 2020-02-17 |
| Catalog Number | MDS808210ARE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-17 |