MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-09-29 for ENDURANCE PYRAMID CANE W1300 manufactured by R. Poon Medical Products Co., Ltd..
[21985836]
According to the user's wife, the incident occurred at around 8:30am on friday (b)(6) 2006. The user was entering the bathroom and she heard a noise that sounded like a fall. When she entered the bathroom, she found the user had fallen to the floor and the broken cane was next to him. The user claims that he fell when the outside left leg broke. The user was very dazed by the incident and had to lie on the floor for approximately 15 minutes. The user was taken to the doctor by his wife. The user's wife claimed that he was bruised and cut as a result of the incident, but provided no physical evidence to support the claim.
Patient Sequence No: 1, Text Type: D, B5
[22201793]
The reporter sent pictures of the device to the distributor for eval. It appears that the outside left leg broke where the crossbar is attached. We (the distributor of the device) requested that user return the device for eval; however, the user did not want to return it. We are unable to further determine the cause of the malfunction at this time because we do not have possession of the cane involved in the incident. No similar incidents were reported to the mfr. We will return the device to the mfr for testing if it is returned by the user. In reviewing photo taken by the dealer and sent to us, both outside legs of the cane are bent inward, tending to indicate that at least one leg was wedged or caught before the fall. No corroborating evidence is available as use was alone in the bathroom when the fall occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000282279-2006-00011 |
| MDR Report Key | 2923268 |
| Report Source | 08 |
| Date Received | 2006-09-29 |
| Date of Report | 2006-09-05 |
| Date of Event | 2006-09-01 |
| Date Mfgr Received | 2006-09-07 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2013-01-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | NEW CITY DISTRICT, DANZAO NANHAI, FOSHAN |
| Manufacturer City | GUANGDONG 528216 |
| Manufacturer Country | CH |
| Manufacturer Postal | 528216 |
| Manufacturer Phone | 5785448866 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDURANCE PYRAMID CANE |
| Generic Name | KHY CANE, SAFETY WALK |
| Product Code | KHY |
| Date Received | 2006-09-29 |
| Model Number | W1300 |
| Catalog Number | W1300 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R. POON MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Address | GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-29 |