MEDLINE
Received Jun 12, 2026 · Event occurred May 15, 2026
Report 1417592-2026-02392 · MDR key 25492186
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "CUSTOMER HAS HAD IT FOR A MONTH AND THE FIRST TIME SHE PULLED IT SHE HEARD A THREAD POP, NOW ON BOTH SIDES IT IS COMING APART AT THE SEAMS AND THE HANDLES ARE COMING OFF." 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.
Description of Event or Problem
IT WAS REPORTED THAT "CUSTOMER HAS HAD IT FOR A MONTH AND THE FIRST TIME SHE PULLED IT SHE HEARD A THREAD POP, NOW ON BOTH SIDES IT IS COMING APART AT THE SEAMS AND THE HANDLES ARE COMING OFF."