MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for UNKNOWN manufactured by Unknown.
[106796167]
(b)(4) healthcare is thought to be the initial importer of the device which is a cane (b)(4). However, according to the caregiver, the only identifying marks on the cane are "made in (b)(6)". It is to be noted that all imported (b)(4) canes are "made in (b)(6)". We have issued a label fot the return of the device to confirm if it is a (b)(4) and determine root cause. We are filing this mdr in an overabundance of caution. We do not believe the device is a (b)(4). The end-user reported that the cane broke in two at the adjustment button while in use. His arm was scratched by the jagged part of the broken cane. He was taken to the hospital where he got stitches. The laceration healed well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00022 |
| MDR Report Key | 7468960 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-03-19 |
| Date Facility Aware | 2018-04-11 |
| Report Date | 2018-04-27 |
| Date Reported to FDA | 2018-04-27 |
| Date Added to Maude | 2018-04-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2018-04-27 |
| Model Number | UNKNOWN |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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. Hospitalization | 2018-04-27 |