MAUDE Adverse Event Report: MEDELA LLC NIPPLE SHIELD (UNKNOWN); SHIELD, NIPPLE

Model Number NIPPLE SHIELD (UNKNOWN)

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Skin Tears (2516)

Event Date 02/17/2019

Event Type  Injury  

Manufacturer Narrative

The customer was provided tips and nipple shield sizing information via email and was urged to contact customer service so that her issue could appropriately be addressed.In follow up with a complaint handler on 03/01/2019, the customer indicated that she started out with a smaller nipple shield when her baby was born and went up to 24mm as he got bigger, but it was too small and caused pinching as he breastfed, which led to cracking of her nipples.She indicated that she was between the 27mm and 30mm sizes.The customer alleged that due to the cracks, she developed an infection which she picked up in the hospital where her premature infant was hospitalized, for which she was prescribed medication.She indicated that she was no longer experiencing the issue because she was no longer using the nipple shields.In follow up with a medela clinician on 03/10/2019, the customer was provided with information regarding exclusive pumping and weaning off of the nipple shields.The customer indicated that she found a competitor product that is a 28mm that works for her.The clinician arranged to send the customer 27mm medela flex breast shields for her to try for breast pumping.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 emailed medela llc, indicating that it would be "nice" if there were larger size options for the nipple shields.The customer alleged that the nipple shields were too small for her and caused her nipples to crack.Because of the cracking, she had to use the soft shells for sore nipples, and even those were too small.

Manufacturer Narrative

Correction to section mfr site.

• Brand Name: NIPPLE SHIELD (UNKNOWN)
• Type of Device: SHIELD, NIPPLE
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL
• MDR Report Key: 8457594
• MDR Text Key: 140119433
• Report Number: 1419937-2019-00051
• Device Sequence Number: 1
• Product Code: HFS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NIPPLE SHIELD (UNKNOWN)
• Device Catalogue Number: NIPPLE SHIELD (UNKNOWN)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other