FDA Adverse Event
Injury
Summary report: N
HURRYWORKS
MDR report key: 12085717
·
Received June 29, 2021
Report
- Report Number
- 2438477-2021-00027
- Event Type
- Injury
- Date Received
- June 29, 2021
- Date of Event
- May 8, 2021
- Report Date
- June 29, 2021
- Manufacturer
- COM-DA HEALTHCARE CO.,LTD
- Product Code
- IPS
- UDI-DI
- 00822383571034
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE BRANDED HURRYWORKS. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. WE WILL SUBMIT A FOLLOWUP WHEN NEW DATA BECOMES AVAILABLE. THE TOP OF THE CANE SNAPPED OFF AND EXPOSED METAL AND SCREW WHILE THE USER WAS WALKING IN THE KITCHEN. HE IS SIX FOOT TWO INCHES TALL. THE BROKEN CANE REPORTEDLY PUNCTURED HIS SHOULDER CAUSING BLEEDING AND HIS KNEES FOLDED BACKWARDS. HE ADVISED THAT HE CAN BARELY WALK AT ALL NOW. HE IS LOOKING FOR COMPENSATION. NO ADDITIONAL INFORMAITON HAS BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 979405 | HURRYWORKS | CANE | IPS | COM-DA HEALTHCARE CO.,LTD | HCANE-BK-C2 | 00822383571034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |