MAUDE Adverse Event Report: MEDELA TENDER CARE HYDROGEL

Lot Number 043215

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Inadequate Pain Relief (2388); Reaction (2414)

Event Date 07/03/2017

Event Type  Injury  

Event Description

I am 12 weeks out from breast reduction surgery.My nipples had been experiencing slight pain from surgery and a friend suggested using medela hydrogel pads that nursing mothers use.I thought it would be fine because my incisions have been completely healed.I wore the pads for approximately 10 hours and following removal experienced a reaction from them.The skin which was under the pad, including the nipples, was bright red, with raised bumps in the shape of the medela pad and i experienced burning and itching, not to mention the emotional toll this has taken following 12 weeks of post surgery healing.On the third day, after no visible or symptomatic improvement, i went to an urgent care.I was given a steroid shot to stop the condition from getting any worse and an antibiotic to ward off infection.The doctor advised keeping the area moist with triple antibiotic ointment or lotion, and applying over the counter cortisone cream once a day.This is day four after removing the pads and there is no improvement.Is the product over-the-counter: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using the product: adverse pain from prior breast reduction 12 wks prior.

• Brand Name: TENDER CARE HYDROGEL
• Type of Device: TENDER CARE HYDROGEL
• Manufacturer (Section D): MEDELA
• MDR Report Key: 6696590
• MDR Text Key: 79730616
• Report Number: MW5070852
• Device Sequence Number: 1
• Product Code: NTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/01/2018
• Device Lot Number: 043215
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 94