MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-11 for DRIVE MEDICAL 10339R-1 manufactured by Jan Mao Industries Co., Ltd.
[57053466]
Drive devilbiss healthcare received notice regarding the incident from the enduser's husband, involving a cane, a product imported and distributed by drive devilbiss healthcare. While using the cane, the handle of the cane broke causing her to allegedly jam her wrist into the stem of the cane. An x-ray was taken which showed that her wrist was fractured. A cast was put on and it will remain in place for at least six weeks. This report is based on the information that was provided by the enduser's husband.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00047 |
| MDR Report Key | 6018916 |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-11 |
| Date of Event | 2016-09-01 |
| Date Facility Aware | 2016-09-11 |
| Report Date | 2016-10-11 |
| Date Reported to FDA | 2016-10-11 |
| Date Reported to Mfgr | 2016-10-11 |
| Date Added to Maude | 2016-10-11 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 MEDICAL |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2016-10-11 |
| Model Number | 10339R-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAO INDUSTRIES CO., LTD |
| Manufacturer Address | NO. 181, CHU LIAO RD KAO HSIUNG CITY, TA SU DISTRICT 84045 CH 84045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-11 |