inforMED
MalfunctionFRG

MEDLINE

Received May 5, 2026 · Event occurred Apr 6, 2026

Report 1417592-2026-00906 · MDR key 25089756

Device

Generic name

Wrap, Bonded, Blue Pink, 48x48 Gem5

Catalog number

GEM5148T

Lot number

85825127960

Product problems

  • Material Puncture/Hole

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER IS COMPLAINING ABOUT WRAPS COMING OUT OF THE ORIGINAL PACKAGING WITH HOLES IN WRAP.

Additional Manufacturer Narrative

CUSTOMER IS COMPLAINING ABOUT WRAPS COMING OUT OF THE ORIGINAL PACKAGING WITH HOLES IN WRAP. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.