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

Model Number 02814WG2

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 12/06/2019

Event Type  Injury  

Event Description

The customer stated the water bottle exploded during use, which caused second degree burns.

• Brand Name: WALGREENS WATER BOTTLE
• Type of Device: HOT COLD WATER BOTTLE
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; 11750 12th ave s; burnsville MN 55337
• Manufacturer Contact: paxia her ; 11750 12th ave s; burnsville, MN 55337 ; 9528088364
• MDR Report Key: 9555086
• MDR Text Key: 186518770
• Report Number: 0002183416-2020-00001
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02814WG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• 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): Other