Dear Laurie,

Someone else may have better information than myself, but as I understand it, the MedWatch program is to establish a record of problems associated with any assault by "a product" on one's health.  For example, as a private practice consultant I fill out a MedWatch form with any client's report concerning a breast pump or artificial breast milk (vomiting, diarrhea, error in use).  It is also wise to copy the letter and send it to the respective manufacturer.  MedWatch is for any health-related equipment so would also cover all of our other lactation gadgets.  I just haven't, personally, had to use it for any of those yet.

I believe the MedWatch forms can be obtained from the FDA web site www.fda.gov.  However, I printed off a form and then made mass copies that I have included in each of my consult folders.  This way I have the form there during the consult to get all the required information off the product.  It is only a one page form and then can be faxed to the FDA.  Simple enough!

God Bless,
Penny Lane RN, BA, IBCLC
Maternal & Child Health: Lactation Consulting
Believe - Birth & Breastfeeding Resources
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