Complaints 101
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution
What is a complaint? (definition from FDA CFR)
When was Merz founded?
1908
What product is currently sold by both Ax and Tx?
Xeomin
Who is the head of Quality for Merz North America, Inc (MNA)?
Sam Marotta
Which planet is known as the "Red Planet"?
Mars
What system is used for EMD and non-EMD complaints?
Non-EMD: MasterControl
What are the Merz operating norms?
Assume positive intent
Obligation to engage
Collaborate cross-functionality
What products are owned by Merz Tx?
Cuvposa and Xeomin
Who is the WI site head?
Brian Wallander
Who wrote the famous play "Romeo and Juliet"?
William Shakespeare
Why do we perform a similar complaint search for every complaint?
To ensure an applicable record is not already open for that device. This saves excess effort in creating unneeded records/voids, mitigates risk of overinflating complaint rate, reminds complainant to return device, etc.
What are the Merz values?
Deliver trusted results
Persist in innovation
Commit to customers & colleagues
What product is currently exclusively sold and distributed by BSC?
Coaptite
Who is the head of Quality for Global Tech Ops (GTO)?
Ashley Goldberg
What social media platform is known for its short-form video content, featuring dances, challenges, and trends?
Per FD9000, what information should be reported for every complaint?
Initial Reporter Contact Information
Patient Information (if applicable)
Product Information
Event Description
What are the 3 divisions of Merz?
Aesthetics (Ax), Therapeutics (Tx), and Life Care (previously consumer care)
What products are sold by Merz Tx?
Xeomin, Cuvposa, Coaptite, Prolaryn Plus, and Prolaryn Gel
Who is the Head of Global Tech Ops (GTO)?
Matt Anderson
What is the chemical symbol for the element gold?
Au
Merz North America, Inc. owns the complaint records for which products? (i.e. intake, investigation, and approval)
Radiesse, Radiesse(+), Coaptite, Prolaryn Plus, Prolaryn Gel, Neocutis
What companies are within the Merz Ax umbrella? Bonus 100 pts if you can name the corresponding products.
MNA (Radiesse, Radiesse+, Coaptite, Prolaryn Gel, Prolaryn Plus, Neocutis)
ON Light Sciences, Inc (Describe)
Ulthera (Ultherapy and Cellfina)
Anteis (Belotero)
Merz North America, Inc. is the legal manufacturer of what products?
Radiesse, Radiesse(+), Coaptite, Prolaryn Plus, Prolaryn Gel, Neocutis
Who founded Merz?
Friedrich Merz
What is the capital city of Australia?
Canberra