inforMED
MalfunctionKOX

OSTMEKT MEDICAL ADHESIVE SPRAY

Received May 18, 2026 · Event occurred Apr 13, 2026

Report MW5188397 · MDR key 25209710

Device

Generic name

Solvent, Adhesive Tape

Manufacturer

Unknown

Model number

2OZ

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

I ORDERED OSTMEKT MEDICAL ADHESIVE SPRAY FROM AMAZON.COM (HTTPS://WWW.AMAZON.COM/DP/BOGLRQ4VV4) AND FOUND IT TO BE MISBRANDED. THE LABEL CONTAINS NO RESPONSIBLE PARTY, OR COUNTRY OF ORIGIN. THERE IS NO UDI OR UPC. THE OUTER RETAIL BOX CONTAINS NO LOT OR EXP. IN ADDITION, THE PRODUCT CONTAINS A FLAMMABLE LIQUID (VERIFIED BY LAB TEST) BUT NO WARNINGS ABOUT FLAMMABILITY. IT WAS DELIVERED AS UNDECLARED DANGEROUS GOODS IN VIOLATION OF DOT REGULATIONS. THIS, AND OTHER POTENTIALLY MISBRANDED OSTOMY PRODUCTS, ARE BEING SOLD BY A CHINESE SELLER: 43000. CN. THE PRODUCT WAS REPORTED TO AMAZON BUT REMAINS ACTIVE ON THE AMAZON MARKETPLACE. PLEASE ALSO CHECK OTHER PRODUCTS SOLD UNDER THE OSTMEKT BRAND FOR FDA COMPLIANCE, INCLUDING ADHESIVE REMOVER SPRAY, BARRIER SPRAY, STOMA POWDER, AND STOMA PASTE.