FDA Adverse Event
Injury
Summary report: N
DRIVE DEVILBISS HEALTHCARE F22 ROLLATOR, TALL
MDR report key: 24687747
·
Received March 25, 2026
Report
- Report Number
- 1000292485-2026-00001
- Event Type
- Injury
- Date Received
- March 25, 2026
- Date of Event
- February 21, 2026
- Report Date
- March 25, 2026
- Manufacturer
- CHANG CHENG FA ENTERPRISE CO., LIMITED
- Product Code
- ITJ
- UDI-DI
- 00822383582238
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
PER DISTRIBUTOR MDR #243477-2026-00015: DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER WHO REPORTED THE WELD AT THE CROSSBAR BROKE CAUSING THE END USER TO FALL. THE END USER CAUGHT HIMSELF AND NOTICED A HERNIA THAT EVENING IN HIS GROIN AREA. THE END USER REQUIRED EMERGENCY SURGERY TO REPAIR THE HERNIA. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748179 | DRIVE DEVILBISS HEALTHCARE F22 ROLLATOR, TALL | ROLLATOR | ITJ | CHANG CHENG FA ENTERPRISE CO., LIMITED | GV974RD-T | 00822383582238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Hospitalization| R |