MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for DRIVE 10350-1 manufactured by Jan Mao Industrial Co., Ltd..
[54265728]
Drive devilbiss healthcare received notification from a patient using a cane that drive deviliss healthcare imports and distributes. The patient was walking with the cane, when allegedly the detent button failed causing him to fall. He was taken to the er for x-rays and a cat scan. A torn meniscus was claimed to be the result of the fall and physical therapy was recommended. The patient requested a replacement cane. The alleged product was returned to drive devilbiss healthcare and an evaluation was completed which the detent button was determined to be functional and no other defects observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00042 |
| MDR Report Key | 5936685 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-04-11 |
| Date Facility Aware | 2016-08-09 |
| Report Date | 2016-09-08 |
| Date Reported to FDA | 2016-09-08 |
| Date Reported to Mfgr | 2016-09-08 |
| Date Added to Maude | 2016-09-08 |
| 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 | DRIVE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2016-09-08 |
| Model Number | 10350-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO INDUSTRIAL CO., LTD. |
| Manufacturer Address | PINGGUO COUNTY INDUSTRIAL ZONE BAISE CITY, GUANGXI 531400 CH 531400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-09-08 |