On (b)(6) 2018, we received an email from our distributor based in (b)(6) concerning a report from one of his customers regarding a child that has been admitted to the hospital after swallowing a button battery.The child naturally excreted the battery and was released from the hospital.The distributor could not confirm that this incident involved the battery of our device - the temple touch thermometer with cr2032 (diameter of 20mm with thickness of 3.2mm) lithium battery - or it was from a toy or other product.Although the suspected lot number of this device was not distributed in the usa and is limited only to the (b)(6) market, since a device that is also registered and distributed in the usa is allegedly involved and in order to comply with 21 cfr 803, we are reporting this incident to the agency.
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