MalfunctionIME
INSTANT HOT PACK
Received Jul 2, 2018 · Event occurred Jun 28, 2018
Report 7654275 · MDR key 7654275
Device
Generic name
Instant Hot Pack
Manufacturer
Cardinal Health 200, LlcModel number
11443-512Catalog number
11443-512
Lot number
V8H054
Product problems
- Leak/Splash
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
INSTANT HOT PACK ACTIVATED AND CONTENTS SPILLED TO FLOOR AFTER ACTIVATION. NO CONTENTS REACHED PATIENT; AREA IMMEDIATELY CLEANED BY RN. SEAM AT TOP OF POUCH SEPARATED WHEN PRODUCT WAS SQUEEZED DURING ATTEMPTED ACTIVATION. NO OTHER PUNCTURES OR TEARS NOTED ON POUCH.