MEDLINE
Received Jun 11, 2026 · Event occurred May 6, 2026
Report 3004122598-2026-00027 · MDR key 25476630
Device
Generic name
Tray, Universal Block, No Pharm
Manufacturer
Productos Medline S.a. De C.v.Catalog number
PAIN9013S
Lot number
26BBG208
Product problems
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BETADINE WAS CRACKED/LEAKING IN THE PACK.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BETADINE WAS CRACKED/ LEAKING IN THE PACK. 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.