MAUDE Adverse Event Report: SANCTUARY HEALTH SDN BHD HENRY SCHEIN; DENTAL DAM 6X6 GREEN

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

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

The customer reports 30-45 minutes after a root canal procedure a patient experienced swelling that developed on their left cheek and neck.The patient was taken to the hospital by ambulance.While in the ambulance the patient was administrated (b)(6) and when at the hospital the patient was given a cortisone shot.The patient stayed the night in the hospital and has made a full recovery.

• Brand Name: HENRY SCHEIN
• Type of Device: DENTAL DAM 6X6 GREEN
• Manufacturer (Section G): SANCTUARY HEALTH SDN BHD; no 16 prsn perind kanthan 1; kws perind kanthan; chemor, perak 31200 ; MY 31200
• Manufacturer Contact: christine choo ; 6b 2nd floor, prsn greentown 4; greentown avenue; ipoh, perak 30250 ; MY 30250 ; 052553939
• MDR Report Key: 6231231
• MDR Text Key: 64134889
• Report Number: 3005497907-2016-00001
• Device Sequence Number: 1
• Product Code: EIE
• Combination Product (y/n): N
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1