MAUDE Adverse Event Report: APOTHECARY PRODUCTS LLC WALGREENS WATER BOTTLE; HOT WATER BOTTLE

Model Number 02814WG3

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2023, apothecary products, llc was notified of a potential issue with item 02814wg3 walgreens water bottle.From the communication with the user it was determined that the user did not follow instructions for use provided on device label to heat the water.It is important to note that the instructions and warnings on the packaging include the following: for warm application, fill bottle two-thirds with plain warm tap water only.Fluid should not exceed 120°f (48.9°c) for hot water bottle use.Do not use microwave, conventional oven or stovetop to heat vessel or water.For application to sensitive skins areas, wrap soft cloth or towel around bottle.In addition to the packaging, there is a temperature warning on the neck of the bottle.

Event Description

The user did not follow proper directions for use printed on the label.

• Brand Name: WALGREENS WATER BOTTLE
• Type of Device: HOT WATER BOTTLE
• Manufacturer (Section D): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer (Section G): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer Contact: pankaj jitiya ; 11750 12 th avn south; burnsville, MN 55337
• MDR Report Key: 17004157
• MDR Text Key: 315999929
• Report Number: 0002183416-2023-00001
• Device Sequence Number: 1
• Product Code: FPF
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 02814WG3
• Device Catalogue Number: 02814WG3
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1