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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA AG NIPPLE SHIELD - 24 MM (STANDARD); SHIELD, NIPPLE

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MEDELA AG NIPPLE SHIELD - 24 MM (STANDARD); SHIELD, NIPPLE Back to Search Results
Model Number 89902
Device Problem Fitting Problem (2183)
Patient Problem Pain (1994)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
Customer service advised the customer that the issue she was experiencing while using the nipple shields could be the result of her baby having a powerful suck or she might need to use a different size nipple shield.The customer stated that she had been sized by a lactation consultant due to her baby having latching issues.The customer was sent new 24mm, 20mm, and 16mm nipple shields to try.Her original nipple shields were requested to be returned for testing/evaluation.In follow up with a complaint handler on (b)(6) 2019, the customer indicated she had been using the 24 nipple shields since the day after her daughter was born, but had not experienced the issue until 8 weeks later.She indicated that she experienced the same issue with both the smaller sizes of nipple shields we had sent and her lactation consultant advised that she needed larger sized nipple shields; however, 24mm is the largest she has been able to find.Additionally, the customer alleged that she was prescribed a steroid cream to help heal her nipples and was no longer using any nipple shields because her lactation consultant told her it would affect her milk supply.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
 
Event Description
On (b)(6) 2019, the customer alleged to medela llc that while using the 24mm standard nipple shields her nipple was pulled through the holes, which created four circle marks on her nipple.She additionally alleged that it was very painful, but she had not sought medical attention.
 
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Brand Name
NIPPLE SHIELD - 24 MM (STANDARD)
Type of Device
SHIELD, NIPPLE
Manufacturer (Section D)
MEDELA AG
lattichstrasse 4b
baar zug 6341
SZ  6341
Manufacturer (Section G)
MEDELA AG
lattichstrasse 4b
baar zug, 6341
SZ   6341
Manufacturer Contact
jan kloiber
1101 corporate drive
mchenry, IL 60050
8004358316
MDR Report Key9355618
MDR Text Key167655935
Report Number1419937-2019-00151
Device Sequence Number1
Product Code HFS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
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 Lay User/Patient
Device Model Number89902
Device Catalogue Number89902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Initial Date Manufacturer Received 10/28/2019
Initial Date FDA Received11/21/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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