GERBER NURSING PADS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-13 for GERBER NURSING PADS * manufactured by Gerber.

Event Text Entries

[335329] The concern about the nipple pads is that it contains a hydrogel, and when the product is removed from the breast, pieces of the product stick to the breast and might be ingested by a nursing baby. There is no ingredient statement on this product and reporter believes it is a medical device rather than a cosmetic. The nipple creams apparently caused a rash around a baby's mouth. The nipple creams are nothing more than oils, lanolin and a mixture of botanical extracts. The concern is whether the material is safe for consumption by an infant and also whether the bits left present a choking hazard. Pieces of the product may remain on the breast and be ingested by the baby. Besides the fact that some studies show that the use of such an occlusive dressing can actually increase the rate of infection, depending on how they are used, there are also continuing concerns about the materials used in these dressings and whether they are safe for consumption by baby. The office was particularly concerned about this one from gerber, since the dressing does not stay intact when removed from the skin. Small pieces of it continued to come off on fingers as reporter touched it. Reporter can also see small pieces of it left on the breast to create a choking hazard for the baby if the mom fails to remove all the pieces left behind. This one is particularly bad in that regard. Furthermore, it can be purchased directly by the mother without ever having seen a health care provider to assess for infection or latch. Reporter believes this is a dangerous product and that it is being marketed in a very inappropriate way.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1031831
MDR Report Key523158
Date Received2004-04-13
Date of Report2003-12-18
Date Added to Maude2004-05-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGERBER NURSING PADS
Generic NameBREAST THERAPY GEL PATCHES
Product CodeNAE
Date Received2004-04-13
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key512286
ManufacturerGERBER
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2004-04-13

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