Quality Event and Returns Report Form

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Submission and Contact Information

FRM # 00402-011 Rev H

Form completed by(Required)

(Name)

Email (to receive a copy of this form submission)(Required)

Site (Hospital Name, City & State)(Required)

Type N/A if unknown

Country(Required)

Physician Name(Required)

Type N/A if unknown

Physician Title

Physician Email(Required)

Enter N/A if unknown

Physician Phone

Physician Fax

Select Reporting Purpose:(Required)

Report a Quality Event (with or without Return): complaint/device deficiency, damage, report of injury, or product non-compliance

Return a Product Only

Will any product associated with the Quality Event be returned?(Required)

Yes

Select Reason for Return(Required)

Administrative Return: associated with an order entry error, shipping error, customer order error, company owned loaner product, or trunk stock return

Expired Product Return: product returns for expired product

Field Safety Corrective Action Return: associated with a removal of product from distribution for marketing or business reasons "market withdrawal" or "stock recovery"

Quality Event and Returns Report Form

Submission and Contact Information

Quality Event Details

Adverse Event Details

Product Information

Product 1

Product 2

Product 3

Product 4

Product 5

Returns - Product 1

Returns - Product 2

Returns - Product 3

Returns - Product 4

Returns - Product 5

Returns - Product 6

Returns - Product 7

Returns - Product 8

Returns - Product 9

Returns - Product 10