Compliance Assessment Process Steps

Intake

1. Upon receipt of a Customer Report/Feedback record, generate a record in NS by creating a New ADV – Customer Report/Feedback

2. Describe relevant details and information reasonably known about the event at the time it is reported.

1. Write chronologically based on how the event unfolded
2. Include only factual information that directly relates to the event.
3. Include symptoms, device allegation, and user/patient outcome.
4. Include follow up /additional information obtained
5. Describe any intervention  completed to address the reported event (change in battery, environment, etc)
6. If the event is reported from media or literature, document applicable source information.  When the event described does not provide specific detail, create one record.

3. Notify the Factory of the customer feedback.

• Use the following form to notify Jiacom of NC Thermometers
  • JIACOM 8D CORRECTION ACT REPORT

Assessment

OTC

Serious adverse event reports received through the address or telephone number described on the product label, and follow-up reports of new medical information, must be submitted to FDA no later than 15 business days after a report of a serious adverse event or the new medical information is received by the responsible person. It is recommended that all serious adverse event reports received by the responsible person be submitted to the FDA within 15 business days of receipt.

A serious adverse event is an event that has one or more of the following patient outcomes or, based on reasonable medical judgment, requires a medical or surgical intervention to prevent one of the following patient outcomes:

• Death
• A life-threatening experience
• In-patient hospitalization, including prolongation of existing inpatient hospitalization
• Persistent or significant disability or incapacity
• Congenital anomaly or birth defect