MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for MEDLINE LIGHTWEGITH & USER-FRIENDLY WHEELCHAIR MDS806550E manufactured by Medline Industries, Inc..
[182224020]
The medline wheelchair does not include instructions or the tools required to assemble the wheelchair properly. The arms of the wheel chair slide into the chair frame and snap in place with spring pins. After adjusting the arm height there are two clamps that should be used to secure the arms in place. Without tightening these clamps, the only thing holding the pt when defending stairs are the two spring clips. The box from the mfr does not include the allen wrench needed to tighten these clamps or instructions on how to properly assemble the chair. I called medline customer service and they could not tell me the size of the allen wrench needed. In my opinion this is an unsafe condition. The chair should be sent out with an allen wrench tied to the chair with a warning label. Tell the assembler that the clamps must be tightened before use. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093488 |
| MDR Report Key | 9780075 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-25 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE LIGHTWEGITH & USER-FRIENDLY WHEELCHAIR |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2020-03-02 |
| Model Number | MDS806550E |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |