MERITS P321B-SGMUBRecalls & reported problems
Merits Health Products CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04714379292916), received between Dec 24, 2025 and Dec 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K011687); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT DISASSEMBLED THE POWER WHEELCHAIR FOR PORTABILITY. THE PATIENT DID NOT COVER THE BATTERY CONNECTION BLOCK WITH THE PROTECTIVE SAFETY COVER ATTACHED TO THE POWER WHEELCHAIR. THIS ACTION LEFT THE BATTERY CONNECTOR POINTS EXPOSED. WHEN THE PATIENT WENT TO LIFT THE SCOOTER, THEIR METAL WATCH BAND SHORTED ACROSS THE TWO BATTERY CONNECTOR POINTS. THE RESULT WAS A BURN TO THE PATIENTS WRIST. THE PATENT RECEIVED NON-HOSPITALIZATION MEDICAL ATTENTION.
Patient problems: Burn(s)
MAUDE report 23888632 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K011687. One submission often covers many models, so check the product and lot details in each record.
- Z-1504-2021 · Apr 1, 2021 · Open, ClassifiedPower Wheelchair
Other Wheelchair, Powered devices
- SmartDrive® MX2+Max Mobility, LLC · Wheelchair, Powered858 reports
- Permobil M3Permobil, Inc. · Wheelchair, Powered1 recall59 reports
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx TDXSP2-MCGInvacare Corporation · Wheelchair, powered2 recalls2 reports
- TDX SP2 with LiNX Electronics TDXSP2Invacare Corporation · Wheelchair, powered2 recalls0 reports
- Invacare® TDX SP2 with Captain's Seat TDXSP2VInvacare Corporation · Wheelchair, powered2 recalls0 reports
- Q6 Edge 3Pride Mobility Products Corp · Wheelchair, Powered4 deaths86 reports
- Q6 Edge 2.0 Q6 Edge 2.0 / Q6 Edge 2.0 with iLevelPride Mobility Products Corp · Wheelchair, Powered1 death83 reports
- Permobil M5Permobil, Inc. · Wheelchair, Powered1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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