MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for NOVA FORTE ROLLATOR 4323BL manufactured by Unk.
[181528847]
Pt was using a four wheeled walker in his home when the cross bar frame suddenly snapped and caused the pt to fall, hitting his head. Nova medical, (b)(6) us. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093305 |
| MDR Report Key | 9754228 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-22 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| 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 | NOVA FORTE ROLLATOR |
| Generic Name | WALKER, MECHANICAL |
| Product Code | ITJ |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-22 |
| Model Number | 4323BL |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |