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

Model Number 02816CV1

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 01/16/2022

Event Type  Injury  

Event Description

The customer claimed to have got burned using hot water bottle.

Manufacturer Narrative

On april 5, 2022, (b)(6) notified apothecary products, llc of a potential quality issue with item 02816cv1 (b)(6) water bottle.The complaint alleged that the water bottle leaked, and the consumer, experienced burns on her right buttocks.It was reported that she went to (b)(6) and was treated.The water was heated in a kettle before putting it in the water bottle by the customer.This is contra to the instructions for safe use provided with the product.It is important to note that the general instructions and warnings on the packaging provided with the product include the following information for safe use: instructions for use: fill bottle two-thirds with plain warm tap water only.Let out excess air before threading in stopper.Thread stopper into bottle.Make sure stopper is in securely.Do not overtighten.Test for leakage by turning bottle upside down and pressing firmly.Warnings/caution: fluid should not exceed 120°f (48.9°c) for hot water bottle use.Carefully examine bottle before each use.If it shows signs of wear (cracks, dryness, bubbles, etc.), it should be discarded.Do not use microwave, conventional oven, or stovetop to heat vessel or water.For application to sensitive skin areas, wrap soft cloth or towel around bottle.Apothecary products regularly monitors all customer feedback to ensure that we take quick action to resolve our customers' concerns.Apothecary products is committed to providing the highest quality products to our customers.

• Brand Name: CVS 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 ; 9528088330
• MDR Report Key: 14256849
• MDR Text Key: 290441683
• Report Number: 0002183-2022-00003
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 02816CV1
• Device Catalogue Number: 02816CV1
• Date Manufacturer Received: 04/05/2022
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female