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

Model Number 87123NA

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

A replacement box of hydrogel pads were sent to the customer so she could return them to a store for a refund.On (b)(6) 2017, a medela clinician followed up with the customer and she reported that she went to urgent care and received a steroid shot and also went to her doctor and was prescribed diprolene cream.She has not used the pads since the one time on (b)(6) 2017.She indicated that the rash was clearing up, but as of (b)(6) 2017, there was still redness outlining the pads.The product involved in the complaint has not been returned for evaluation/investigation at this time.Reported issues of rash were investigated under in (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 or (2) pathogens or allergens that come in contact with exposed hydrogel pads which would subsequently be introduced to the user¿s breast.The customer filed a voluntary medwatch report under mw5070852.

Event Description

On (b)(6) 2017, the customer alleged that she used the tender care hydrogel pads on (b)(6) 2017 and was apparently allergic to them, as they caused her skin to become red and she developed a rash covering the area where the pad was.

• Brand Name: TENDER CARE HYDROGEL PADS
• Type of Device: NURSING PAD, HYDROGEL
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6742009
• MDR Text Key: 80987313
• Report Number: 1419937-2017-00206
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• 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: 07/11/2017
• Date Manufacturer Received: 07/11/2017
• 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