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

Model Number 87123

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)

Event Date 04/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the customer alleged to medela llc that she had a reaction to the hydrogel pads after wearing them for two hours and the doctor recommended that she use cortisone and vaseline but it didn't work.Additionally, the customer alleged that the skin which was under the pad, including the nipples, was bright red, with raised bumps in the shape of the medela pad along with burning and itching.

Manufacturer Narrative

Customer service sent the customer some lanolin cream and suggested she contact her doctor.In follow up with a complaint handler on 5/3/2022, the customer stated that she went to the doctor at 3 am because her skin was burning and she couldn't sleep.The customer indicated that she was crying and the doctor prescribed her cortisone to apply on both breast, but it didn¿t work.Additionally, the customer indicated that at 10 am she went to (b)(6) and the doctor prescribed her steroids to apply on both breast as well, but it didn't work again.The customer also stated it wasn't an allergic reaction, the hydrogel pads burned my skin.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

• Brand Name: TENDER CARE HYDROGEL PADS
• Type of Device: NURSING PAD, HYDROGEL
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14516845
• MDR Text Key: 292791619
• Report Number: 1419937-2022-00050
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2022
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female