Reporter
Last name, First name
Position
Address-Phone-Fax-E-mail
Healthcare institution
Association / Manufacturer
Home
Other
MEDICAL DEVICE INVOLVED
Common name
Trade name
Model
Type
Reference
Serial or Lot number
Software version
Supplier's name and address
Manufacturer's name and address
INCIDENT OR POTENTIAL INCIDENT
Date of occurrence
Location of occurrence
User references
Circumstances of occurrence / Description of facts
Observed clinical consequences
Conservative measures and actions taken
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