FDA Adverse Event
Summary report: N
CANES
MDR report key: 2862671
·
Received December 10, 2012
Report
- Report Number
- 1531186-2012-01648
- Date Received
- December 10, 2012
- Report Date
- November 7, 2012
- Manufacturer
- HL CORP. (SHENZHEN)
- Product Code
- IPS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INCORRECT INFORMATION WAS SUBMITTED ON THE INITIAL MEDWATCH.
Description of Event or Problem · 1
A COMPANY REPRESENTATIVE HAS REPORTED AN EVENT OF A BENT QUAD CANE. STATED THAT THE BACK STRAIGHT LEG ON THE QUAD CANE IS BENT INWARDS TOWARDS THE LEG THAT IS AT A 45 DEGREE ANGLE. PATIENT STATES THIS LEG BENT AND IT CAUSED HIM TO FALL AND THAT HE WAS NOT INSTRUCTED ON HOW TO USE THE CANE. HE HAD BEEN USING A CANE SINCE (B)(6) 2012. NO INJURY REPORTED. PLEASE NOTE ANY FURTHER INFORMATION WILL BE FILED IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANES | 890.3075 | IPS | HL CORP. (SHENZHEN) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 MO | Other |