NEOSPORIN SCAR SOLUTION
Received Feb 28, 2007 · Event occurred Jul 20, 2006
Report 2246407-2007-00001 · MDR key 823812
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Johnson & Johnson Group Of Consumer Cos.Model number
*Catalog number
*
Lot number
21666-3
Product problems
- Improper or Incorrect Procedure or Method
Patient
0 DAY
- Low Apgar Score
- Hospitalization required
Narrative
Description of Event or Problem
A PREGNANT FEMALE CONSUMER REPORTED USING ONE NEOSPORIN SCAR SOLUTION SHEET (SILICONE) DAILY BEGINNING ON AN UNK DATE IN 2005 TO REDUCE THE APPEARANCE OF A SCAR. HER EXPECTED DUE DATE WAS 22-DEC-2006. PRODUCT USE WAS DISCONTINUED ON AN UNK DATE IN 2006. AS OF THE FOLLOWING MONTH, THE OUTCOME OF THE PREGNANCY WAS UNK. ADD'L INFO REC'D ON 20-FEB-2007 VIA A PREGNANCY QUESTIONNAIRE HAS UPGRADED THIS CASE TO SERIOUS. A PREGNANT FEMALE CONSUMER USED ONE SHEET OF NEOSPORIN SCAR SOLUTION SHEET (SILICONE) ABOUT EVERY TWELVE HRS DAILY IN 2005. PRODUCT USE WAS DISCONTINUED IN 2006. THE CONSUMER'S EXPECTED DUE DATE WAS EIGHT MONTHS LATER. TWO MONTHS EARLIER, THE CONSUMER, GAVE BIRTH TO A NINE-WEEK PREMATURE INFANT MALE. THE BABY WAS FOUR POUNDS AND SEVENTEEN INCHES LONG. AT ONE MIN, HIS APGAR SCORE WAS 8.9. THE INFANT SPENT SIX AND ONE HALF WEEKS IN THE NEONATAL INTENSIVE CARE UNIT (NICU). AS OF 2007, THE OUTCOME OF THE EVENT WAS UNK.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.