MAUDE Adverse Event Report: PELTON & CRANE LIGHT FANTASTIC III TRACK MOUNT DENTAL LIGHT; DENTAL OPERATING LIGHT

Model Number HBT-3

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

A dentist was positioning a pelton & crane dental light for use when the light arm assembly allegedly broke causing the light to fall down towards the ground.The light allegedly grazed the doctors forehead causing a minor scratch.There were no serious injuries reported.

Manufacturer Narrative

Pelton & crane asked the dentist to return the components in question to pelton & crane for evaluation as a result of the alleged complaint.However, the dr refuses to cooperate and said they will not return the parts to pelton & crane.

• Brand Name: LIGHT FANTASTIC III TRACK MOUNT DENTAL LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4827008
• MDR Text Key: 15588976
• Report Number: 1017522-2015-00011
• 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
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBT-3
• Device Catalogue Number: LFTIII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2007
• 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
• Patient Age: 41 YR