MAUDE Adverse Event Report: HENRY SCHEIN; MAXITEMP HP KIT

Catalog Number 900-1281

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

Patient Problem Asthma (1726)

Event Date 07/15/2021

Event Type  Injury  

Event Description

A (b)(6) year-old male patient claims that a day after having a crown preparation done in their mouth they were experiencing an anaphylactic reaction.A day after the crown preparation was in the patient's mouth the patient was at home when they used an epipen themselves then went to the emergency room.The patient was discharged two days later and given steroids.The same day the patient was discharged they requested the crown that was placed in their mouth to be removed and it was removed.Two days later the patient was in the emergency room again.

Event Description

The initial report submitted on 08/05/2021 for this incident had the incorrect manufacturer information.We were informed on 08/13/2021 by the manufacturer what needed to be corrected, therefore we are sending this report to the manufacturer and have updated section d: suspect medical device and the manufacturer information under section f: user facility/importer on this medwatch report.

• Brand Name: HENRY SCHEIN
• Type of Device: MAXITEMP HP KIT
• MDR Report Key: 12280869
• MDR Text Key: 265167567
• Report Number: 2411236-2021-00001
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/16/2021,08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 900-1281
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2021
• Distributor Facility Aware Date: 07/16/2021
• Event Location: Home
• Date Report to Manufacturer: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR