MEDLINE
Received Jun 25, 2026 · Event occurred May 26, 2026
Report 1417592-2026-02877 · MDR key 25627121
Device
Generic name
Drape,c-arm,kit,full
Manufacturer
Medline Industries, LpCatalog number
DYNJE4500
Lot number
06925110011
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DRAPE REQUIRES RUBBER BANDS OR OTHER MEANS TO SECURE IT FOR THE PROCEDURE AND THE MATERIAL IS TIGHT AND RIPS EASILY.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DRAPE REQUIRES RUBBER BANDS OR OTHER MEANS TO SECURE IT FOR THE PROCEDURE AND THE MATERIAL IS TIGHT AND RIPS EASILY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. 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 IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.