MAUDE Adverse Event Report: HENRY SCHEIN, INC. MAXITEMP HP KIT, PRODUCT CODE: E; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 900-1281

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

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.Fda safety report id # (b)(4).

• Brand Name: MAXITEMP HP KIT, PRODUCT CODE: E
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): HENRY SCHEIN, INC.
• MDR Report Key: 12324507
• MDR Text Key: 266849878
• Report Number: MW5103230
• Device Sequence Number: 1
• Product Code: EBG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900-1281
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• 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