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

Model Number	16811-DS
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Tip cut infant when used.

• Brand Name: THERMOMETER DUAL SCALE ORAL CLINICAL
• Common Device Name: 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
• MDR Report Key: 6083487
• Report Number: 1423537-2016-00056
• Device Sequence Number: 1359622
• Product Code: FLL
• UDI-Device Identifier: 00885380023883
• UDI-Public: (01)00885380023883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Distributor Facility Aware Date: 09/30/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 11/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 DA