CARA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-12 for CARA manufactured by Cara.

Event Text Entries

[21757020] The consumer stated that a hot water bottle she purchased triggered her allergies 2 days ago. The consumer was in the process of filling the hot water bottle, when she noticed the natural rubber surface was sticky. The consumer rinsed and dried the water bottle in water mixed with dishwashing liquid to remove the sticky substance. The consumer proceeded to fill the water bottle and placed the water bottle with warm water underneath her husband's stomach as she laid in bed with him. The consumer, within a few minutes, noticed that the water was emitting a strange odor. The consumer picked up the water bottle and placed it in her bathtub. The consumer could feel her breathing becoming more difficult and her asthma worsening. She is also experiencing headaches and coughing. The consumer was not treated for her symptoms. The consumer stated that the bottle is still intact. The consumer stated that the bottle did not damage her bed sheets or cause property damage. The consumer called the firm yesterday and was told that they have not had any complaints. The consumer called the retailer and the retailer asked to take back the product. The consumer has opted not to give back the product. The water bottle is 2 quarts in capacity and beige in color. Cpsc document number: (b)(4). Report number: (b)(4). Retailer: (b)(6). The product was not damaged before the incident. The product was not modified before the incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5024037
• MDR Report Key: 2434411
• Date Received: 2012-01-12
• Date of Report: 2012-01-12
• Date of Event: 2012-01-10
• Date Added to Maude: 2012-02-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARA
• Generic Name: 2 QT RUBBER CARA HOT WATER BOTTLE
• Product Code: FPF
• Date Received: 2012-01-12
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-01-12