MAUDE Adverse Event Report: PELTON & CRANE DELTA XL STERILIZER 10"

Model Number AF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

The distributor took the sterilizer back to their repair facility for evaluation.They noticed the chamber water filter was a little dirty and nothing else.They have run the sterilizer for over a week without failure (over 10 complete cycles).They will return the sterilizer to the dr as is.The use and care manual and warning labels on the device warn the user to be aware of steam when opening up the sterilizer door as steam may bellow upwards when the door is initially opened after a cycle.Device not returned.

Event Description

A dental assistant was preparing to start a cycle on a delta xl 10" sterilizer and opened the door when steam came out and burned her hand causing a second degree burn.She went to the er and they wrapped her hand, gave her over the counter pain medication, and gave her a prescription for norco.

• Brand Name: DELTA XL STERILIZER 10"
• Type of Device: STERILIZER
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 6356920
• MDR Text Key: 68269715
• Report Number: 1017522-2017-00007
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: AF
• Device Catalogue Number: AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2008
• 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 Outcome(s): Other