SHOE COVER
Received Jan 19, 2013 · Event occurred Dec 31, 2012
Report 1417592-2013-00006 · MDR key 2929384
Device
Generic name
Shoe Cover
Manufacturer
Medline Industries, Inc.Catalog number
NON28758
Lot number
12GXFA0501
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Dysphagia/ Odynophagia
Narrative
Description of Event or Problem
CONCERN THAT A CHILD SWALLOWED A PIECE OF ELASTIC FROM A SHOE COVER.
Additional Manufacturer Narrative
A PIECE OF ELASTIC WAS FOUND IN THE DIAPER OF A CHILD IN THE DAY CARE SETTING AND THOUGHT TO HAVE COME FROM THE SHOE COVERS USED BY PARENTS AND STAFF. NO SAMPLE WAS RETURNED FOR EVAL. NO ONE WITNESSED THE CHILD WITH A PIECE OF ELASTIC IN HIS/HER MOUTH AND NO PREVIOUS COUGHING OR CHOKING WAS OBSERVED. NO PHOTOS WERE PROVIDED. WE HAVE NOT CONFIRMED THE SHOE COVER TO BE THE SOURCE OF THE ELASTIC PIECE FOUND IN THE DIAPER. WE HAVE NO TREND FOR THIS ISSUE. THERE WAS NO INJURY TO THE CHILD.