MUNCHKIN COLOR FLOW-SAFETY NIPPLE (NEWBORN TO 3 MOS SLOW-FLO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-16 for MUNCHKIN COLOR FLOW-SAFETY NIPPLE (NEWBORN TO 3 MOS SLOW-FLO * manufactured by Munchkin, Inc..

Event Text Entries

[109303] A 6 week old infant was thought to have breast feeding problem. "munchkin" slow flow nipple "one step drop in" feeding system was started. Normal growth was halted. Baby gained little or no weight from 6 weeks to 4 months (4. 5 kg to 10. 0 lbs), and gained only one lb 4 months to 5. 5 months of age. Baby hospitalized for failure to thrive, and flow-restriction nipple identified by pediatric nurses. Pediatrician still did not recognize problem. Mother resumed feeding with slow-flow nipple and munchkin feeding system. From hospital discharge to re-admission (5. 75 months to 8 months)baby again only gained about 6 ounces in weight. Finally, munchkin system abandoned, baby thriving. Now on routine bottle/nipple system. Now 18 lbs 12 oz. Pediatrician writes: " my great concern in this case is three-fold. One: the parent failed to comply with the directions of the manufacturer, which are only printed on the disposable box and package insert. Two: several pediatricians, both military and civilian, appear to be unaware of this product and so the child's failure to thrive condition continued needlessly for many months. Three: in my own opinion as a pediatrician there is no legitimate need for nipples that restrict nutrient flow to normal infants. Contrary to popular belief, nipples and artificial feeding systems designed for premature infants and babies with various sucking problems generally allow for increased nutrient flow for weak and impaired infants. When i spoke with one customer service representative of the company involved (munchkin in van nuys, california), there was a less-than-receptive response to my report of this concerning case. I suggested to them by phone, and will be following up by letter, that a warning notice, perhaps on the box, in pediatric medical journals, or in personal mailings be sent to pediatricians and family practitioners around the country regarding low-flow nipple feeding systems. Thank you for your consideration. Every company manufacturing artificial feeding systems for infants in this company appears to be making a 'low-flow' or 'slow-flow' or 'newborn' nipple. The advertising claims include statements like 'decreases colic in the newborn' (newborns do not get colic), 'preferred by breast feeding specialists' (it is likely true that infants will be unlikely to prefer a nipple that gives very little flow over the free flowing human nipple after mother's milk let down) and encourages vigorous sucking' (which they certainly do, until the infant exhausts). I believe normal infants should not be given their primary nutrition through low or slow-flow nipples. In the case of this pt. - documented vigorous sucking to the point of sweating accompanied by the infant's tendency to tire before she could get enough nutrition for growth through the slow-flow nipple. Thank you for your consideration. It appears to me we pediatricians are terribly unaware of these products and their potential to cause or contribute to failure to thrive.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1014181
MDR Report Key177703
Date Received1998-07-16
Date of Report1998-07-02
Date of Event1998-05-08
Date Added to Maude1998-07-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMUNCHKIN COLOR FLOW-SAFETY NIPPLE (NEWBORN TO 3 MOS SLOW-FLO
Generic NameBABY BOTTLE NIPPLE
Product CodeFNN
Date Received1998-07-16
Model Number*
Catalog Number*
Lot Number*
ID NumberPATENT# 5,544,766
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key172793
ManufacturerMUNCHKIN, INC.
Manufacturer Address8257 WOODLEY AVE. VAN NUYS CA 914061298 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 1998-07-16
20 1998-07-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.