MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING CO 1, LLC. D-LISH HOLIDAY PASTE; PROPHY PASTE

Model Number 295011

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

Patient Problem Anaphylactic Shock (1703)

Event Date 01/20/2015

Event Type  Injury  

Manufacturer Narrative

Not a device problem.

Event Description

Patient had an allergic reaction after using the paste - anaphylactic shock.

• Brand Name: D-LISH HOLIDAY PASTE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING CO 1, LLC.; 13705 shoreline ct. e.; earth city MO 63045
• Manufacturer Contact: sarah moore ; 13705 shoreline ct. e.; earth city, MO 63045 ; 3143440010
• MDR Report Key: 5442749
• MDR Text Key: 38414589
• Report Number: 1941138-2016-00005
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: 295011
• Device Catalogue Number: 295011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening