MAUDE Adverse Event Report: DR. BROWNS / HANDI-CRAFT CO. DR BROWN DELUXE BOTTLE STERILIZER; STERILIZER, STEAM

Catalog Number	AC045
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Potential heavy metals being leached into baby bottles via dr browns deluxe sterilizer.The heating element wither rusts or flakes off and turns all the plastic inside a rust color.This rust/ metal could be getting into the bottles.I even used distilled water and this still happened.Other users report the same problem on (b)(6) via their reviews.Fda safety report id # (b)(4).

• Brand Name: DR BROWN DELUXE BOTTLE STERILIZER
• Common Device Name: STERILIZER, STEAM
• Manufacturer (Section D): DR. BROWNS / HANDI-CRAFT CO.
• MDR Report Key: 10717634
• Report Number: MW5097372
• Device Sequence Number: 3102884
• Product Code: FLE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: AC045
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1