JOHNSON & JOHNSON
Received Sep 22, 2004
Report MW4003805 · MDR key 562718
Device
Generic name
Nursing Pads
Manufacturer
Johnson & Johnson Consumer Prod CoModel number
*Catalog number
*
Lot number
*
Product problems
- Foreign material
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
RPTR WAS VERY CONCERNED THAT THERE APPEARED TO BE SMALL CRYSTALS OR TINY PLASTIC BALLS BEING INGESTED BY PT FROM THE NURSING PADS. THE BOX DOES NOT HAVE ANY WARNING OR STATEMENT THAT THERE MAY BE A LEAK IN THE PADS AND TO BE CAREFUL TO NOT ALLOW THE PT TO INGEST THE MATERIAL, BUT INSTRUCTIONS FOR USE STATE TO CLEAN THE BREAST BEFORE EACH BREASTFEEDING SESSION. RPTR HAS NOTICED THE SMALL WHITE BEADS/BALLS OF MATERIAL TWICE; THE FIRST TIME THEY HAD THOUGHT IT WAS MILK AND WIPED IT AWAY BUT REALIZED THE SECOND TIME. IT MAY HAVE OCCURRED MORE OFTEN WITHOUT NOTICING. PT HAS EXPERIENCED ACID REFLUX FREQUENTLY AND RPTR IS UNSURE IF IT MAY BE RELATED TO THE POSSIBLE INGESTION OF THIS MATERIAL.