MAUDE Adverse Event Report: PELTON AND CRANE; DENTAL LIGHT

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

Pelton and crane was contacted alleging that a light fell into a patients lap.No injury was reported.The light has been repaired by an authorized dealer and will not be returned for evaluation.The doctor has not been able to provide the manufacturer identifiers or at a minimum a photo of the alleged light.Should additional information be provided to the manufacturer identifying the dental light, a follow up mdr will be submitted.

Event Description

Pelton and crane was notified that a dental light allegedly fell into a patients lap.No injuries reported.

Manufacturer Narrative

Pelton & crane was contacted on october 13th, 2021 alleging that the patient had been injured as a result of this incident.Pelton & crane reached out for additional details of the alleged injury but has not been able to obtain additional information to date.Should additional information be provided to the manufacturer detailing the alleged injury and the device identifier for the dental light, a follow up mdr will be submitted.This concludes this update.

Event Description

Pelton & crane was contacted on october 13th, 2021 alleging that the patient had been injured as a result of this incident.No additional details of the injuries have been provided.

• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): PELTON AND CRANE; 11727 fruehauf dr; charlotte NC 28273
• Manufacturer (Section G): PELTON AND CRANE; 11727 fruehauf dr; charlotte NC 28273
• Manufacturer Contact: crystal bialek ; 11727 fruehauf dr; charlotte, NC 28273 ; 7042886058
• MDR Report Key: 12316148
• MDR Text Key: 266397787
• Report Number: 1017522-2021-00005
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1