FDA Adverse Event
Injury
Summary report: N
DRIVE DEVILBISS HEALTHCARE
MDR report key: 20094576
·
Received August 29, 2024
Report
- Report Number
- 3014644996-2024-00013
- Event Type
- Injury
- Date Received
- August 29, 2024
- Date of Event
- August 8, 2024
- Report Date
- August 29, 2024
- Manufacturer
- COM-DA HEALTHCARE CO.,LTD
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
PER DISTRIBUTOR MDR: 2438477-2024-00045: (B)(6) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE PROVIDER WHO STATED THAT THE WALKER BECAME "WOBBLY", THE LEG BROKE AND THE END USER FELL. THE END USER SUSTAINED LOOSE TEETH AND A LACERATION TO THE LIP. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, (B)(6) HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1766459 | DRIVE DEVILBISS HEALTHCARE | WALKER | ITJ | COM-DA HEALTHCARE CO.,LTD | R726BL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |