MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-29 for MEDIUM BASE QUAD CANE 3920-2 manufactured by Invacare.
[51225894]
Fell face first, injured nose, lips, gums, wrists and hands, at the sudden fracture of a quad cane. The cane was used less than one year, which has a three year warranty and a 5 year service life. The cane has a weight limitation of 250 lb, which is (b)(6) lb greater than the user. The fracture occurred eight inches from the bottom of the handle piece. This is a two piece quad cane. Wear was seen inside the handle section and in the height adjustment hole that confirmed the height and use throughout the period in use. Also, observed the fracture occurred near the top of leg section, on the handle section at an adjustment hole. The results of the failure analysis revealed a very serious danger due to the likelihood of the user falling and causing injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063801 |
| MDR Report Key | 5842979 |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-29 |
| Date Added to Maude | 2016-08-03 |
| 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 |
| 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 | MEDIUM BASE QUAD CANE |
| Generic Name | MEDIUM BASE QUAD CANE |
| Product Code | IPS |
| Date Received | 2016-07-29 |
| Model Number | 3920-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-29 |