MAUDE Adverse Event Report: COLTENE WHALEDENT INC. SPEC 3 LED USA PLUG TYPE A; CURING LIGHT

Model Number	60013941
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Female patient was numbed, and dr used the spec 3 light to cure the filling material.The light was pointed towards the tooth, on the standard mode, and the light caused a burn to form on the side of the patient's tongue.The patient is now in pain from the burn, and the dr is complaining that the light is getting too hot and overheating.
Additional Manufacturer Narrative
Investigation: no product returned.The customer stated that the curing light caused a burn to form on the side of the patient's tongue.Multiple attempts were made to contact the customer to obtain additional information regarding the adverse event and to request the unit be returned for evaluation; however, to date, there has been no response from the customer and the product has not been returned.Due to the lack of information, a proper investigation and root cause analysis cannot be performed.Root cause: since root cause analysis could not be performed, the product risk file and product engineer were consulted to determine several possible root causes.Causes of curing light causing burns, as per product engineer 1.The device is repeatedly activated causing the surface of the unit to become hot (exceed 45 degrees c).Serious per risk analysis (b)(4) revision e (e7) 2.The power output of the led exceeded the range the spec 3 is programmed for which caused the unit to heat up excessively.Severity: serious (evaluated by product engineer) 3.The temperature shut off failed allowing the unit to exceed a safe operating temperature.Severity: serious (evaluated by product engineer).

• Brand Name: SPEC 3 LED USA PLUG TYPE A
• Common Device Name: CURING LIGHT
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223
• MDR Report Key: 13807267
• Report Number: 2416455-2022-00006
• Device Sequence Number: 2084001
• Product Code: EBZ
• UDI-Device Identifier: D661600139410
• UDI-Public: D661600139410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60013941
• Device Catalogue Number: 60013941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female