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

Model Number 87123

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Customer service replied with an response, encouraging the customer to make contact via phone so that her issue could appropriately be addressed.In follow up by a complaint handler with the customer on (b)(6) 2018, the customer responded that she started using the gel pads 3 days after delivery for irritated nipples from breastfeeding.She stated that she only wore the gel pads for about 2 hours when she noticed a burning sensation and then saw marks on her breast.She indicated that she stopped using the gel pads, visited her lactation consultant (who consulted her obgyn), and was prescribed a compound steroid cream.The customer indicated that the burns are still noticeable, but are healing.She stated that she has discarded the unused 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) 2018, the customer alleged to medela llc via email that the tender care hydrogel pads burned her skin terribly.

• Brand Name: TENDER CARE HYDROGEL PADS
• Type of Device: NURSING PAD, HYDROGEL
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7577801
• MDR Text Key: 110362607
• Report Number: 1419937-2018-00141
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 87123
• Device Catalogue Number: 87123
• Device Lot Number: 051016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• 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