MAUDE Adverse Event Report: GRAND BOND ELECTRONICS LIMITED RITE AID MINI DIGITAL TEMPLE TOUCH THERMOMETER; TEMPLE TOUCH MINI,

Model Number FHT6C

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 03/05/2018

Event Type  Injury  

Event Description

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.

• Brand Name: RITE AID MINI DIGITAL TEMPLE TOUCH THERMOMETER
• Type of Device: TEMPLE TOUCH MINI,
• Manufacturer (Section D): GRAND BOND ELECTRONICS LIMITED; room 2207-b 22f cct telecom bl; 11-19 wo shing street; hong kong, 000 ; CH 000
• Manufacturer (Section G): GRAND BOND ELECTRONICS LIMITED; room 2207-b 22f cct telecom bl; 11-19 wo shing street; hong kong, 000 ; CH 000
• Manufacturer Contact: hila tubi-shwartzman ; g.g. communication center; harey yehuda; neve ilan, 90850 ; IS 90850
• MDR Report Key: 7405796
• MDR Text Key: 104671001
• Report Number: 9616787-2018-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FHT6C
• Device Catalogue Number: MDTT1
• Device Lot Number: 5216
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• 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 Age: 3 YR