inforMED
MalfunctionFMP

GEL-E DONUT

Received Apr 21, 2014 · Event occurred Apr 19, 2014

Report MW5035755 · MDR key 3770946

Device

Generic name

Gel-e Donut

Lot number

92025-C

Product problems

  • Device Contamination with Chemical or Other Material
  • Packaging Problem

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

PRODUCT WAS REMOVED FROM ORIGINAL PACKAGING AND NOTED TO HAVE BLACK MOLD GROWING ON IT. A NEW PRODUCT WAS REMOVED FROM SAME BOX AND NOTED TO HAVE SAME PROBLEM, ALL EXCEPT FOR 2 OF THESE IN THIS SAME BOX WERE NOTED TO HAVE MOLD ON THEM. ALL PRODUCTS "BEST USED BY" DATE IS 11-2004. PRODUCTS WERE KEPT SEALED IN PLASTIC FROM MFR, IN MFR'S ORIGINAL BOX IN A CLEAN, DRY LOCATION IN THE NURSERY AND NOT RESPOND TO LIGHT OR EXCESSIVE TEMPERATURES. DIAGNOSIS OR REASON FOR USE: INDICATED AS A HEAD SUPPORT OR POSITIONING AIR FOR NEWBORNS.