Product Complaint — Metiska Farma

Product Quality Complaint — Non-Critical

Complaints related to technical quality that do not endanger patient safety.

1) Complaint information

Complaint received by

Date received

Where the issue was found

Phone number

2) Customer information

Customer

Email (if any)

Phone number

Customer address

Incident date

Purchase date

Place of purchase

Institution (if any)

3) Product information

Product name

Packaging

Dosage form

Batch number

Expiry date

Strength

Quantity complained

Sample quantity submitted

Masterbox supporting data (if any)

Complaint description

4) Reporter information

Reporter

Report date

5) Upload documents

I am not a robot

Contact: info@metiska.co.id

Medical Device Quality Complaint — Non-Critical

Complaints related to technical quality of medical devices that do not endanger patient safety.

1) Complaint information

Complaint received by

Date received

Where the issue was found

Phone number

2) Customer information

Customer

Institution name

Customer address

Phone number

Incident date

Purchase date

Place of purchase

3) Product information

Product name

Batch number

Expiry date

Dosage form

Packaging

Strength

Quantity complained

Sample quantity submitted

• Data penunjang dari masterbox :

Weight

Masterbox number

Top seal

Bottom seal

Complaint description

4) Upload documents

I am not a robot

Contact: info.alkes@metiska.co.id

Adverse Event — Critical Category

Complaints related to pharmacological effects and/or harmful side effects.

1) Complaint Information

Patient Name

Ethnicity

Age

Address

Sex

Body Weight

Comorbidities / Concomitant Conditions

Primary Disease Complaint

2) Reaction Information

Description of the primary disease based on diagnosis (laboratory results)

Initial signs or symptoms of the reaction

Examinations (check all that apply)

Examination Result

If death: date

Is the reaction related to death?

3) Adverse Effect Information

Symptoms / manifestation of the adverse effect

History of adverse effects previously experienced

Onset date

Outcome of the adverse effect

4) Suspected Product Information

Product Name

Batch Number

Expiry Date

Daily Dose

Route / Instructions for Use

Indication

Start of Use

End of Use

Did the symptoms improve after stopping the product?

Did the symptoms reappear after reusing the product?

Has the product been used before?

Was the product previously tolerated?

5) Other products used concomitantly*

Were there any other products used concomitantly?

Complete card # dulu.

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6) Treating Doctor Information

Doctor Name

Specialty

Doctor Address

7) Adverse Event Reporter Information

Reporter

Report date

8) Upload documents

I am not a robot

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Contact: farmakovigilans.tim@metiska.co.id

Product Complaint Form

Product Quality Complaint — Non-Critical

1) Complaint information

2) Customer information

3) Product information

4) Reporter information

5) Upload documents

Medical Device Quality Complaint — Non-Critical

1) Complaint information

2) Customer information

3) Product information

4) Upload documents

Adverse Event — Critical Category

1) Complaint Information

2) Reaction Information

3) Adverse Effect Information

4) Suspected Product Information

5) Other products used concomitantly*

6) Treating Doctor Information

7) Adverse Event Reporter Information

8) Upload documents