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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT NIPPLETTE; NIPLETTE
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PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT NIPPLETTE; NIPLETTE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Breast Discomfort/Pain (4504)
Event Type  Injury  
Manufacturer Narrative
The device has been designed according to safety standards and is safe to use when used according to the dfu.The device has been requested for analysis.
 
Event Description
Consumer claims after she has used the niplettes for about 2 weeks, her nipples hurt, got misshaped and turned purple.Her doctor told her it would take months to heal.Consumer also thinks she might need plastic surgery.
 
Manufacturer Narrative
Despite the efforts taken by philips to retrieve the device and gather more information, the device was not returned for analysis.The device has been designed according to applicable safety standards and is safe when used as directed by the instructions for use.According to the warnings that are included in our instructions for use, excessive suction force applied to the nipple could cause pain, blisters, swelling, bleeding or discharge of fluid.We direct the user to decrease the amount of suction and if the symptoms persist, to contact a healthcare professional.We consider this specific complaint/event closed.
 
Event Description
Consumer claims after she has used the niplettes for about 2 weeks, her nipples hurt, got misshaped and turned purple.Her doctor told her it would take months to heal.Consumer also thinks she might need plastic surgery.
 
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Brand Name
PHILIPS AVENT NIPPLETTE
Type of Device
NIPLETTE
Manufacturer (Section D)
PHILIPS CONSUMER LIFESTYLE B.V.
tussendiepen 4
drachten, nld NLD92 066A
NL  NLD92066AD
MDR Report Key11563510
MDR Text Key242062126
Report Number3010359222-2021-00001
Device Sequence Number1
Product Code HGY
Combination Product (y/n)N
PMA/PMN Number
K952035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/26/2021
Initial Date FDA Received03/24/2021
Supplement Dates Manufacturer Received02/26/2021
Supplement Dates FDA Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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