MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-02-14 for MDS808210ARE manufactured by Medline Industries Inc..
[100117481]
It was reported that the back part of the transport chair collapsed and customer experienced a fall resulting in a fracture of the left forearm. The customer's daughter reported that the customer was sitting in a locked transport chair when the back part of the chair collapsed on itself resulting in the customer falling on her back left side and fracturing her left forearm. The customer was on vacation and was taken to a local clinic where an x-ray was performed and confirmed a fracture to the left forearm. No additional diagnostic imaging was reported. The customer required surgical intervention to set the reported fracture. The transport chair involved in the incident was reportedly discarded and is not available to be returned for evaluation. Due to the reported incident and the need for surgical intervention, this medwatch is being filed. In the even that additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[100117482]
It was reported that the back part of the transport chair collapsed and customer experienced a fall resulting in a fracture of the left forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00008 |
| MDR Report Key | 7271438 |
| Report Source | OTHER |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-02-14 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSPORT CHAIR,ALUM, BASIC,12" WHL |
| Product Code | INM |
| Date Received | 2018-02-14 |
| Catalog Number | MDS808210ARE |
| Lot Number | UNK |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-14 |