TENDER CARE HYDROGEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for TENDER CARE HYDROGEL manufactured by Medela.

Event Text Entries

[79730616] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5070852
• MDR Report Key: 6696590
• Date Received: 2017-07-07
• Date of Report: 2017-07-07
• Date of Event: 2017-07-03
• Date Added to Maude: 2017-07-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TENDER CARE HYDROGEL
• Generic Name: TENDER CARE HYDROGEL
• Product Code: NTC
• Date Received: 2017-07-07
• Lot Number: 043215
• Device Expiration Date: 2018-08-01
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDELA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-07-07