MAUDE Adverse Event Report: MEDELA LLC TENDER CARE HYDROGEL PADS; NURSING PAD, HYDROGEL

Model Number 87123NA

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

Patient Problems Erythema (1840); Swelling (2091); Urticaria (2278); Reaction (2414)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

In follow up with the customer on (b)(6) 2017, the customer responded that she may have an allergy to one of the ingredients in the hydrogel pads that she didn't know about, and will have to avoid coming in contact with it in the future.She indicated that she was prescribed an antibiotic and stopped using the hydrogel pads immediately, though the product was very helpful in doing what it was designed to do, but just didn't work with her sensitive skin.She stated that she discarded the product.Reported issues of rash related to the hydrogel pads were investigated under (b)(4), which determined the probable root causes to be (1) customers with glycerin allergies experiencing aggressive immune reactions due to the fact that glycerin is an integral ingredient in the hydrogel pads and (2) pathogens or allergens that come in contact with exposed hydrogel pads which would subsequently be introduced to the user¿s breast.

Event Description

On (b)(6) 2017, the customer alleged via email to medela llc that she used the tender care hydrogel pads for the first time and experienced a severe allergic reaction.The product worked well at first until her entire breasts became covered in hives, swollen and red all over.To her knowledge, she didn't have allergies to the listed ingredients, but did indicate an allergy to latex.She wanted to know if there was any latex in the product; otherwise, she may have discovered another allergy.

• Brand Name: TENDER CARE HYDROGEL PADS
• Type of Device: NURSING PAD, HYDROGEL
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7036384
• MDR Text Key: 92153631
• Report Number: 1419937-2017-00320
• Device Sequence Number: 1
• Product Code: NTC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 87123NA
• Device Catalogue Number: 87123NA
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/24/2017
• Date Manufacturer Received: 10/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other