FDA Adverse Event
Summary report: N
CANES
MDR report key: 2586384
·
Received May 24, 2012
Report
- Report Number
- 1531186-2012-00314
- Date Received
- May 24, 2012
- Report Date
- May 21, 2012
- Manufacturer
- HL CORP. (SHENZHEN)
- Product Code
- IPS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE CONSUMER IS A (B)(6) MALE. THE CONSUMER STATED THAT HE RECEIVED THE CANE FROM THE VA AND IT DID NOT HAVE A SUPPORT COLLAR. THE CANE IS ALLEGEDLY WOBBLY WHEN HE ATTEMPTS TO USE IT. CONSUMER IS TO RETURN THE CANE BACK TO THE VA FOR A REPLACEMENT. NO INJURY. NO RMA ISSUED.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE RECEIVED CANE WITHOUT THE SUPPORT COLLAR. NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANES | 890.3075 | IPS | HL CORP. (SHENZHEN) | 3920-2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 MO | Other |