FDA Adverse Event
Injury
Summary report: N
DRIVE
MDR report key: 10063484
·
Received May 15, 2020
Report
- Report Number
- 2438477-2020-00028
- Event Type
- Injury
- Date Received
- May 15, 2020
- Report Date
- May 15, 2020
- Manufacturer
- HOMECARE ENTERPRISE CO., LTD.
- Product Code
- IPS
- UDI-DI
- 00822383246451
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE. CANE WAS NOT RETRIEVED FOR EVALUATION. CANE SNAPPED IN HALF WHILE IN USE. END-USER FELL AND BROKE HIS GLASSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525403 | DRIVE | CANE | IPS | HOMECARE ENTERPRISE CO., LTD. | RTL10372BK | 00822383246451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |