MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-04-11 for BED, MANUAL VC5310 manufactured by Land America Health & Fitness.
[4464686]
End user allegedly has no feeling in his right leg, was having spasms in bed rubbing his leg up against the bed rail which had a sharp edge, tbm stated the consumers right leg got all scratched up and they had to take him to the hospital, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-01350 |
| MDR Report Key | 3747048 |
| Report Source | * |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-13 |
| Date Facility Aware | 2014-03-14 |
| Report Date | 2014-04-11 |
| Date Reported to FDA | 2014-04-11 |
| Date Reported to Mfgr | 2014-04-11 |
| Date Added to Maude | 2014-04-11 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BED, MANUAL |
| Generic Name | 880.5120 |
| Product Code | FNJ |
| Date Received | 2014-04-11 |
| Model Number | VC5310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAND AMERICA HEALTH & FITNESS |
| Manufacturer Address | 25 NORTH 2ND RD XIAMEN FUJIAN PROVINCE 361022 CH 361022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-11 |