FYIClass I
Appliance, Facial Fracture, External
General, Plastic Surgery · 21 CFR 878.3250
MDR events20All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances4All time
Recent MDR events
20 adverse event reports on file
- THE VEST SYSTEMNov 3, 2025MalfunctionBaxter Healthcare Corporation3008145987-2025-00019
- THE VEST SYSTEMOct 15, 2025MalfunctionBaxter Healthcare Corporation3008145987-2025-00014
- VEST, MODEL 105 BLEJul 5, 2024InjuryHill-rom Singapore3008145987-2024-00017
- VEST MODEL 105Jun 27, 2024MalfunctionHill-rom Singapore3008145987-2024-00016
- CONTROLLER, VEST 105Jun 12, 2024MalfunctionHill-rom Singapore3008145987-2024-00015
- VEST, MODEL 105 BLEApr 23, 2024InjuryHill-rom Singapore3008145987-2024-00011
- CONTROLLER, VEST 105Mar 25, 2024InjuryHill-rom Singapore3008145987-2024-00009
- CONTROLLER, VEST 105Feb 1, 2024MalfunctionHill-rom Singapore3008145987-2024-00004
- VEST MODEL 105Nov 13, 2023MalfunctionHill-rom Singapore3008145987-2023-00021
- VEST, MODEL 105 BLENov 13, 2023MalfunctionHill-rom Singapore3008145987-2023-00022
Event type breakdown
Malfunction12
Injury8
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Material Split, Cut or Torn9
Adverse Event Without Identified Device or Use Problem5
Appropriate Device Problem Term/Code Not Available2
Overheating of Device2
Disconnection1
Flare or Flash1
Material Frayed1
Sparking1
Trend for “Material Split, Cut or Torn”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
4 clearances for this product code