Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-07-07 | VAI | Voluntary action indicated | AliMed Corporation | 1 |
| 2016-07-07 | VAI | Voluntary action indicated | AliMed Corporation | 1 |
| 2011-03-04 | NAI | No action indicated | AliMed Corporation | 0 |
| 2011-03-04 | NAI | No action indicated | AliMed Corporation | 0 |
Similar devices
- """L"" type anesthesia screen " SKYTRON LLC
- "12"" Carbon fiber arm surgery board for 3000 & 3003 (36"" & 48"" extensions)" SKYTRON LLC
- "18"" Foot extension " SKYTRON LLC
- "40"" CARBON FIBER EXTENSION " SKYTRON LLC
- "40"" Carbon Fiber Extension " SKYTRON LLC
- "5"" Table side extension with release lever " SKYTRON LLC
- "FHC Custom 4"" Stretcher Pad w/Black Comfort Cover" FUTURE HEALTH CONCEPTS, INC.
- "FHC Custom Table Pad w/Drain Flap 1"" Purple Fusion, No Velcro" FUTURE HEALTH CONCEPTS, INC.
- "LDPE STIFFENER 24"" X 18"" X 1/16 """ SKYTRON LLC
- "Pad Amsco (3080/3085) 2"" Thick (Set Of 3)" FUTURE HEALTH CONCEPTS, INC.
- "Pad FHC 1000 Deluxe Patient Transfer Extension 18""W X 25""L X 1""T" FUTURE HEALTH CONCEPTS, INC.
- 5 Piece Split Leg Accessory Cart SKYTRON LLC
Select up to two to place side-by-side with this device.