MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for CAREX FGA51700 BRNZ A517-00 manufactured by .
[86330342]
The user states that he has two canes that he had purchased about six months ago. He uses both of the canes simultaneously, one for each hand. He states that he was using the canes, and the shaft of one of them bent, and he fell. He states that he was hospitalized for a month with fractured ribs, bruised kidneys, and also had a heart attack because of the stress of falling. He did also mention that the cane "gives a little. " the event is reported as having occurred on a linoleum surface in a bathroom. The rubber feet of the cane are reported as having been free of splits, cracks, or tears, and its lock knob is reported as having been properly tightened, the snap button also functioning properly.
Patient Sequence No: 1, Text Type: D, B5
[110479726]
The device involved with this event was returned to compass health brands and evaluated on 11/14/2017. The customer's complaint could be confirmed from a review of the returned device. The returned cane was found to have the lower section of its frame/tubing bent in a forward "10 o'clock position" - the frame/tubing appears to look like it is crimped as a result of the bend. This bend happened 9 inches above the base of the cane - the measured diameter of the lowest section of the tubing was 19. 09mm. The bend was measured as width & width (vertically & horizontally), because it is no longer a circle - the bend measured at 10. 55mm & 24. 78mm; the largest measurement is due to the tubing flattening out. The handle grip was also found to have electrical tape wrapped around it. Again, the customer's complaint could be confirmed from a review of the returned device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00117 |
| MDR Report Key | 6869056 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-12-07 |
| Date Facility Aware | 2017-08-21 |
| Report Date | 2017-12-07 |
| Date Reported to FDA | 2017-12-07 |
| Date Added to Maude | 2017-09-15 |
| 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 | 3 |
| Brand Name | CAREX |
| Generic Name | OFFSET ADJUSTABLE DESIGNER CANE |
| Product Code | IPS |
| Date Received | 2017-09-15 |
| Model Number | FGA51700 BRNZ |
| Catalog Number | A517-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-09-15 |