MAUDE Adverse Event Report: K-JUMP HEALTH CO. LTD/DONGGUAN POLYGREEN TECHNOLOGY CO. LTD WALGREENS; INFRARED EAR THERMOMETER

Model Number KI-8171L.WAG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Bestmed was contacted by (b)(6).A consumer was concerned regarding an infrared ear thermometer.Consumer claims the thermometer did not register accurate readings and alleges this caused the miscarriage of the unborn baby.

• Brand Name: WALGREENS
• Type of Device: INFRARED EAR THERMOMETER
• Manufacturer (Section D): K-JUMP HEALTH CO. LTD/DONGGUAN POLYGREEN TECHNOLOGY CO. LTD; msinchiao industrial zone; huangjiang; dongguan, guangdong ; CH
• Manufacturer Contact: gwen lambert ; 331 corporate cir.; suite 3; golden, CO 80401 ; 3032710300
• MDR Report Key: 4749655
• MDR Text Key: 18545840
• Report Number: 1724795-2015-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: KI-8171L.WAG
• Device Catalogue Number: KI-8171L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Distributor Facility Aware Date: 03/10/2015
• Event Location: Other
• Date Report to Manufacturer: 04/10/2015
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: No
• 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