MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for MEDLINE MDS 809850 manufactured by Medline.
[104271732]
Pt arriving to er for medical treatment for low blood glucose, sat down in wheelchair. Leaned backwards in chair and fabric back of wheelchair ripped apart from the wheelchair base, causing the pt to tumble out of the wheelchair backwards, landing on her head on tile/concrete floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7393153 |
| MDR Report Key | 7393153 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-26 |
| Date Facility Aware | 2018-03-26 |
| Report Date | 2018-03-26 |
| Date Reported to FDA | 2018-03-30 |
| Date Reported to Mfgr | 2018-03-27 |
| Date Added to Maude | 2018-04-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | MEDLINE |
| Generic Name | WHEELCHAIR |
| Product Code | KNO |
| Date Received | 2018-03-30 |
| Returned To Mfg | 2018-04-01 |
| Model Number | MDS 809850 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | NORTHFIELD IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |