FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 6018916
·
Received October 11, 2016
Report
- Report Number
- 2438477-2016-00047
- Event Type
- Injury
- Date Received
- October 11, 2016
- Date of Event
- September 1, 2016
- Report Date
- September 11, 2016
- Manufacturer
- JAN MAO INDUSTRIES CO., LTD
- Product Code
- IPS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669739 | DRIVE MEDICAL | CANE | IPS | JAN MAO INDUSTRIES CO., LTD | 10339R-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |