MAUDE Adverse Event Report: MEDELA AG SOFTSHELLS - SORE NIPPLES; SHIELD, NIPPLE

Model Number 80210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Fungal Infection (2419)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Medela customer service responded to the customer's review on (b)(6) and asked her to call in or chat so that her issue could appropriately be addressed.As of the date of this report, the customer has not done so.The complaint handler was unable to follow up with the customer due to lack of contact information.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

On (b)(6) 2020, the customer alleged in an (b)(6) review that the medela softshells for sore nipples that she had purchased caused mastitis and a fungal infection after using them for less than one day.She additionally alleged that she had taken antibiotics for ten (10) days and the redness was gone, but she had not fully recovered because she had pain that felt like needles and she was still taking anti-fungal medicine.Additionally, she stated her baby was no longer able to breastfeed because of her swollen nipples.

• Brand Name: SOFTSHELLS - SORE NIPPLES
• 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 dr; mchenry, il ; 4358316
• MDR Report Key: 10157024
• MDR Text Key: 195267810
• Report Number: 1419937-2020-00058
• Device Sequence Number: 1
• Product Code: HFS
• UDI-Device Identifier: 00020451802107
• UDI-Public: 020451802107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853176
• 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: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 80210
• Device Catalogue Number: 80210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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