MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for MCKESSON 195-2571 manufactured by Caremax Rehab Equip Co, Limited.
[106843335]
Customer was walking with the quad cane. The cane snapped as she stumbled. No injury was reported. Inspection records for the reported serial number were reviewed and no nonconformities were noted. The cane passed inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2018-00002 |
| MDR Report Key | 7469068 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-03-30 |
| Date Facility Aware | 2018-03-29 |
| Report Date | 2018-04-23 |
| Date Reported to Mfgr | 2018-04-23 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 0 |
| Brand Name | MCKESSON |
| Generic Name | QUAD CANE |
| Product Code | IPS |
| Date Received | 2018-04-27 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | 195-2571 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREMAX REHAB EQUIP CO, LIMITED |
| Manufacturer Address | PINGNAN INDUSTRIAL REGION, GUI FOSHAN CITY, GUANGDONG 528251 CH 528251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-27 |