MEDLINE
Received Jul 15, 2026 · Event occurred Jul 10, 2023
Report 1417592-2026-05938 · MDR key 25830685
Device
Generic name
Pack,gel,hot/cold,reusable 6x10.625
Manufacturer
Medline Industries, LpCatalog number
MDS138020
Lot number
RA22214
Product problems
- Gel Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER SAID HE TOOK THE PACK OUT TO GET IT WARM FOR USE AND NOTICED IT WAS LEAKING GEL. CANNOT FIND WHERE IT IS LEAKING AT JUST KNOWS THAT THE GEL GETS ON HIS HANDS. 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. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW ACTIVITIES, WHICH INCLUDE REVIEW OF HISTORICAL DATA IN ACCORDANCE WITH REGULATIONS AT 21 CFR PART 803. THE INFORMATION INCLUDED IN THIS MDR REFLECTS THE INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THE TIME OF THIS RETROSPECTIVE REVIEW AND SUBMISSION.
Description of Event or Problem
CUSTOMER SAID HE TOOK THE PACK OUT TO GET IT WARM FOR USE AND NOTICED IT WAS LEAKING GEL.