MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-05-05 for MDS808210ARE manufactured by Medline Industires, Inc..
[44552114]
The end user's daughter reported that while sitting in the transport chair, the right leg broke and the end user fell. She was taken to the hospital and had x-rays taken of her legs, shoulder and hip. She was diagnosed with a fracture in her right clavicle. A soft sling was applied and pain medication given. She was discharged to home. Photos that were provided showed the right backrest tube was fractured below the folding mechanism. A sample has not been received for evaluation. The lot number has not been provided. The overall care and condition of the transport chair is not known. We have no information to indicate a manufacturing defect caused or contributed to the incident. A root cause has not been determined. Due to the reported injury, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[44552115]
The end user's daughter reported that her mother was sitting in the transport chair and the right leg broke and she fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00054 |
| MDR Report Key | 5635121 |
| Report Source | CONSUMER |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-03-13 |
| Date Mfgr Received | 2016-04-08 |
| Date Added to Maude | 2016-05-05 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2016-05-05 |
| Catalog Number | MDS808210ARE |
| Lot Number | UNK |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTIRES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-05 |