MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-24 for WALGREENS 271063 manufactured by Raise Medical Industries, Inc..
[48137517]
Drive medical received a notice of incident which involved a quad cane that drive medical has been sourcing for (b)(6). The end user was using the cane while going down the three wide concrete steps of their property. As he came to the bottom step, one of the prongs of the cane bent inward. The cane tore his leg as he was falling. His left leg was allegedly wounded from knee to half way down his shin. This report is based solely on the information provided by the wife of the end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00024 |
| MDR Report Key | 5748572 |
| Date Received | 2016-06-24 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-03-25 |
| Report Date | 2016-06-09 |
| Date Reported to FDA | 2016-06-09 |
| Date Reported to Mfgr | 2016-06-09 |
| Date Added to Maude | 2016-06-24 |
| 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 | WALGREENS |
| Generic Name | CANE |
| Product Code | KHY |
| Date Received | 2016-06-24 |
| Model Number | 271063 |
| Catalog Number | 271063 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAISE MEDICAL INDUSTRIES, INC. |
| Manufacturer Address | PHASE 1, JIANGLI NORTH ROAD NANSHA INDUSTRIAL VILLAGE FOSHAN CITY, GUANGDONG 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-06-24 |