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

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.

• 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 Key: 9355618
• MDR Text Key: 167655935
• Report Number: 1419937-2019-00151
• Device Sequence Number: 1
• Product Code: HFS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923577
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 89902
• Device Catalogue Number: 89902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/28/2019
• 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 Number: 1
• Patient Outcome(s): Other