MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for NARROW BASE QUAD CANE 1616710022 3920-2 manufactured by Pinghu Weifeng Material Technology.
[45065330]
End user is stating the following: that he has a defective model 3920-2, stating that he was walking with his wife in their neighborhood on dry level sidewalk when for no reason the four pronged cane came apart and the end user fell down making his wife fall on the ground also. End user is alleging that he had bruised ribs from the fall. Update from consumer affairs on 04/19/2016: end user called back and sent photos of the broken cane. The dealer picked up the cane but did not return it to us and location of product is unknown at this time. They think it was thrown away when they exchanged it. End user said he was just walking along and it snapped in half and he fell on his wife. No broken bones but he was sore and had an x-ray done to confirm he did not break anything. End user had soreness and bruising. No further information provided or expected at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2016-00012 |
| MDR Report Key | 5650852 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-04-19 |
| Date Facility Aware | 2016-04-19 |
| Report Date | 2016-04-29 |
| Date Reported to FDA | 2016-04-29 |
| Date Reported to Mfgr | 2016-04-29 |
| Date Added to Maude | 2016-05-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | NARROW BASE QUAD CANE 1616710022 |
| Generic Name | CANE |
| Product Code | KHY |
| Date Received | 2016-05-12 |
| Model Number | 3920-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 13 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PINGHU WEIFENG MATERIAL TECHNOLOGY |
| Manufacturer Address | PINGHU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-05-12 |