MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-19 for ENDURANCE HEAVE DUTY QUAD CANE RPM70061 W1306 manufactured by Foshan R. Poon Medical Products.
[89822313]
End user reports walking on linoleum floor in home when the leg of her quad cane broke causing her to fall and hit her head and knee. No medical attention was sought but patient reports ongoing pain. All identifying labeling had been removed from cane, but appearance is similar to ems product no. W1306, heavy duty quad cane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2017-00012 |
| MDR Report Key | 6962965 |
| Date Received | 2017-10-19 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-01 |
| Date Facility Aware | 2017-09-25 |
| Report Date | 2017-10-19 |
| Date Reported to FDA | 2017-10-19 |
| Date Reported to Mfgr | 2017-10-19 |
| Date Added to Maude | 2017-10-19 |
| 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 | 0 |
| Brand Name | ENDURANCE HEAVE DUTY QUAD CANE |
| Generic Name | QUAD CANE |
| Product Code | IPS |
| Date Received | 2017-10-19 |
| Model Number | RPM70061 |
| Catalog Number | W1306 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOSHAN R. POON MEDICAL PRODUCTS |
| Manufacturer Address | NEW CITY DISTRICT DANZAO, NANHAI FOSHAN, 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |