MAUDE Adverse Event Report: HANGZHOU SEJOY ELEC & INST CO LTD THERMOMETER DUAL SCALE ORAL CLINICAL; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 16811-DS

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Laceration(s) (1946)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the returned samples indicated the metal end of the thermometer was slightly oversize.This had resulted in the slight burrs when assembled, which translated into the reported rough edge.Review of incoming records for the metal edge indicated that all inspected materials were within specification.Inspection of (b)(4) pieces of samples from the existing material lot# 20161020 were conducted without finding any non conformances.A review of the device history record for the reported lot number 59776004160146-sh showed no incidents. the problem was immediately reported to the responsible supplier.Process improvements include tightening current incoming inspections and adding additional inspections.Sop's have been updated and training has been provided to all related operators and inspectors.From the investigation, the root cause was due to isolated incident of metal tip oversize.This was a problem that originated from the tip supplier.

Event Description

Tip cut infant when used.

• Brand Name: THERMOMETER DUAL SCALE ORAL CLINICAL
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): HANGZHOU SEJOY ELEC & INST CO LTD; bldg 2 no 202 west lake econom; hangzhou 130 3 0003; CH 130 300030
• Manufacturer (Section G): HANGZHOU SEJOY ELEC & INST CO LTD; bldg 2 no 202 west lake econom; hangzhou 130 3 0003; CH 130 300030
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6083487
• MDR Text Key: 59837547
• Report Number: 1423537-2016-00056
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00885380023883
• UDI-Public: (01)00885380023883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16811-DS
• Device Catalogue Number: 16811-DS
• Device Lot Number: 59776004160146-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/30/2016
• Event Location: Hospital
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 DA