MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for HURRYCANE UNKNOWN manufactured by Unknown.
[125181590]
(b)(4) is the initial importer of the device which is a cane. The end-user's daughter cannot confirm the model number of the cane. She believes it is a hurrycane. In an overabundance of caution we are filing "thie" report to document the incident. The end-user fainted and collapsed onto her cane. There was no defect to the cane. The patient cut her leg requiring 53 stitches. Pms is "awiting" additional "informaiton" and device retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00057 |
| MDR Report Key | 8010225 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-06-09 |
| Date Facility Aware | 2018-09-26 |
| Report Date | 2018-10-26 |
| Date Reported to FDA | 2018-10-26 |
| Date Added to Maude | 2018-10-26 |
| 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 |
| 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 | HURRYCANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2018-10-26 |
| Model Number | UNKNOWN |
| 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. Required No Informationntervention | 2018-10-26 |