inforMED
MalfunctionINP

MEDLINE GUARDIAN BARIATRIC HEAVY DUTY PUSH BUTTON CRUTCHES

Received Jun 9, 2015 · Event occurred Jun 9, 2015

Report 4837584 · MDR key 4837584

Device

Generic name

Crutches

Model number

*

Catalog number

MDS80335XW

Lot number

40315010001

Product problems

  • Device Contamination with Chemical or Other Material

Patient

*

  • No Information

Narrative

Description of Event or Problem

CRUTCHES CAME IN WITH A SUBSTANCE THAT LOOKED LIKE TINY BALLS OF METAL INSIDE THE SEALED PACKAGE.======================MANUFACTURER RESPONSE FOR HEAVY DUTY PUSH BUTTON CRUTCHES, GUARDIAN (PER SITE REPORTER).======================I CONTACTED THE DISTRIBUTOR. THAT IS WHERE WE GET THE CRUTCHES FROM. THEY ARE SENDING ME SHIPPING MATERIAL TO SEND THE CRUTCHES BACK.