MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-05 for ENDURANCE PYRAMID CANE RPM70020 W1300 manufactured by Foshan R. Poon Medical Products Co., Ltd.
[5843345]
Dealer reported to sales rep that a pyramid cane had been returned with a broken leg. The user did not report an injury or fall. The contact information for the user was obsolete and no other contact information was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2015-00013 |
| MDR Report Key | 4827653 |
| Date Received | 2015-06-05 |
| Date of Report | 2015-05-18 |
| Date of Event | 2015-05-12 |
| Date Facility Aware | 2015-05-18 |
| Report Date | 2015-05-18 |
| Date Reported to FDA | 2015-06-05 |
| Date Reported to Mfgr | 2015-06-04 |
| Date Added to Maude | 2015-06-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 6420 HAZELTINE NATIONAL DR. |
| Manufacturer City | ORLANDO FL 32822 |
| Manufacturer Country | US |
| Manufacturer Postal | 32822 |
| Manufacturer G1 | ESSENTIAL MEDICAL SUPPLY, INC. |
| Manufacturer Street | 6420 HAZELTINE NATIONAL DR. |
| Manufacturer City | ORLANDO FL 32822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32822 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANCE PYRAMID CANE |
| Generic Name | PYRAMID CANE |
| Product Code | KHY |
| Date Received | 2015-06-05 |
| Returned To Mfg | 2015-06-05 |
| Model Number | RPM70020 |
| Catalog Number | W1300 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD |
| Manufacturer Address | NEW CITY DISTRICT, DONZAO, NANHAI, FOSHA 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-05 |