FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 3072281
·
Received April 19, 2013
Report
- Report Number
- 2438477-2013-00010
- Event Type
- Injury
- Date Received
- April 19, 2013
- Date of Event
- January 18, 2013
- Report Date
- March 22, 2013
- Manufacturer
- HL CORP (SHENZHEN)
- Product Code
- IPS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DRIVE MEDICAL HAS REC'D A SUMMONS FROM CLAIMANT'S ATTORNEY COMPLAINING ABOUT AN INCIDENT INVOLVING A LARGE BASE QUAD CANE ALLEGEDLY IMPORTED AND DISTRIBUTED BY DRIVE MEDICAL. THE ATTORNEY LETTER STATED THAT THE CLAIMANT WAS USING THE QUAD CANE AT HOME WHEN IT ALLEGEDLY BROKE IN HALF CAUSING HIM TO FALL. THE CLAIMANT SUSTAINED A CRACKED FEMUR, BROKEN PATELLA AND BROKEN BALL JOINT IN HIP. THIS MDR REPORT IS BASED ON A CLAIMANT'S ATTORNEY STATEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169302 | DRIVE MEDICAL | CANE (PRODUCT CODE: IPS) | IPS | HL CORP (SHENZHEN) | 10385-4 (POSSIBLE) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |