MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for ROSCOE CANE manufactured by .
[39628344]
The end-user was using a roscoe cane (part number is unknown, however, it has been reported that our name [roscoe medical] was on the cane). The tip of the cane cracked, causing the end-user to fall and injure her right knee. The customer had a doctor's appointment on (b)(4) 2016 because her knee was still bothering her. The customer did go to the doctor, and the doctor wants to do an mri. The end-user had foot surgery on (b)(6) 2016, and is still in a lot of pain from her foot surgery - the doctor wants to wait until after her foot heals until following through with an mri.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005182235-2016-00002 |
| MDR Report Key | 5477875 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-03-03 |
| Date of Event | 2016-02-03 |
| Report Date | 2016-03-03 |
| Date Reported to Mfgr | 2016-03-03 |
| Date Added to Maude | 2016-03-03 |
| 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 | ROSCOE CANE |
| Generic Name | CANE/CANE TIP |
| Product Code | INP |
| Date Received | 2016-03-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-03 |