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 NumberMW5024037
MDR Report Key2434411
Date Received2012-01-12
Date of Report2012-01-12
Date of Event2012-01-10
Date Added to Maude2012-02-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCARA
Generic Name2 QT RUBBER CARA HOT WATER BOTTLE
Product CodeFPF
Date Received2012-01-12
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCARA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-01-12

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