MalfunctionFQM

COFLEX LF BANDAGE 1" STERILE

Received Aug 20, 2025 · Event occurred Aug 11, 2025

Report 22850938 · MDR key 22850938

Device

Generic name

Bandage, Elastic

Manufacturer

Andover Healthcare Inc. (a Milliken Healthcare Loc

Model number

DYNJ089001

Catalog number

DYNJ089001

Lot number

25GBO086

Product problems

Defective Device
Wrong Label

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

OUTSIDE OF MANUFACTURERS BOX LABELING STATES "COFLEX LF BANDAGE 1"STERILE". INSIDE PACKAGING STATES "COFLEX LF BANDAGE 1" STERILE". WHAT IS ACTUALLY IN THE PACKAGING IS COFLEX LF BANDAGE 2" STERILE. PRODUCT IS MISLABELED. PRODUCT MISLABEL CAUGHT BEFORE GOING INTO OR SUPPLY CIRCULATION. THE 2" COFLEX IS TOO BIG TO BE USED FOR THE PURPOSE NEEDED IN HAND SURGERY.