MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for QUAD POD BY HUGO manufactured by Amg Medical.
[53320485]
Cane tip sold as quad pod totally failed. Wife requires 2 canes for mobility. First failure was replaced by company. Now a second one has failed. This can cause the user loss of support, stability resulting in a fall. Cane tip sold as quad pod. Retailer: (b)(6). Purchase date: (b)(6) 2016. I still have the product in my possession: no. The product was damaged before the incident: no. The product was modified before the incident: no. Have you contacted the manufacturer: yes. Explanation: they replaced, now a second one has failed. I have photos on ipad does not support flash as you require. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064335 |
| MDR Report Key | 5903665 |
| Date Received | 2016-08-23 |
| Date of Event | 2016-07-29 |
| Date Added to Maude | 2016-08-25 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | QUAD POD BY HUGO |
| Generic Name | QUAD POD BY HUGO |
| Product Code | IPS |
| Date Received | 2016-08-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMG MEDICAL |
| Manufacturer Address | 8505 DALTON MONTREAL, QUEBEC H4T 1V5 CA H4T 1V5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-23 |