MalfunctionLHC
INTRATEMP THERMABASIN DRAPE
Received Jul 26, 2019 · Event occurred Jul 17, 2019
Report 1043549-2019-40002 · MDR key 8831335
Device
Generic name
Fluid Warming & Slush Drapes
Manufacturer
Haywood Vocational OpportunitiesModel number
ITB100Lot number
79059
Product problems
- Material Puncture/Hole
- Material Puncture/Hole
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE, A HOLE WAS OBSERVED IN THE CORNER OF TWO DRAPES. THERE WAS NO HOLE ON THE OUTSIDE OF PACKAGING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.