MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DEMAGNETIZER,MICRO-INSTRUMENT,110VOLT

Catalog Number MDS100001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 the staff member was, 'using the demagnetizer in short intervals allowing the unit to cool in between instruments when they began to feel the unit get warm'.Per the facility after 5-10 minutes the device sparked and started smoking.The facility stated the employee experienced, 'only minor burn injuries which have been resolved'.The sample was returned for evaluation and a definitive root cause could not be determined.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2022 the staff member was, 'using the demagnetizer in short intervals allowing the unit to cool in between instruments when they began to feel the unit get warm'.Per the facility after 5-10 minutes the device sparked and started smoking.

• Type of Device: DEMAGNETIZER,MICRO-INSTRUMENT,110VOLT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15716657
• MDR Text Key: 302876213
• Report Number: 1417592-2022-00210
• Device Sequence Number: 1
• Product Code: LXG
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2022

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
• Device Operator: Other
• Device Catalogue Number: MDS100001
• Device Lot Number: E0822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other