MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-02 for CAREX DESIGNER OFFSET CANE - BLUE FGA51500 BLUE manufactured by Unknown.
[66429368]
This customer had experienced a problem with the blue offset cane. This customer/end-user claims that the strap broke on the cane, causing her to fall and get hurt. The event had occurred in the end-user's home, on laminate flooring, coming into her house via entryway. The end-user was already going to the orthopedic doctor for her foot, and was unable to use crutches, so she was instructed to use a cane. She put the strap on her wrist, and reached out to put her hand on the handle and the strap broke, causing her to fall on her right shoulder. She didn't realize her shoulder was hurt until a few days later. She went back to our customer using one of their electric chairs, and showed the rep that the strap broke and she fell. The rep (from our customer) provided her with a new cane and took the broken one. She went to the orthopedic doctor to follow up on her foot, and she told the doctor her shoulder was hurting. The doctor prescribed medicine first, and that didn't work, so then the doctor gave her a cortisone shot. She is still not feeling better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00011 |
| MDR Report Key | 6297006 |
| Date Received | 2017-02-02 |
| Date of Report | 2017-01-31 |
| Date of Event | 2016-11-10 |
| Date Facility Aware | 2017-01-04 |
| Report Date | 2017-01-31 |
| Date Reported to FDA | 2017-01-31 |
| Date Added to Maude | 2017-02-02 |
| 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 DESIGNER OFFSET CANE - BLUE |
| Generic Name | CANE |
| Product Code | KHY |
| Date Received | 2017-02-02 |
| Model Number | FGA51500 BLUE |
| Lot Number | UNAVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-02 |