MAUDE Adverse Event Report: DENTSPLY BRAZIL VIPI FLASH LIQUID; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number V458

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the health professional's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Though this product is not sold in the us, like products are marketed by dentsply sirona.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a clinician experienced an allergic reaction to vipi flash liquid after coming in contact with the product on his skin.He sought a doctor for treatment.No further details are available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: VIPI FLASH LIQUID
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): DENTSPLY BRAZIL; rua alice herve 86, bingen; petropolis, 25665 -010; BR 25665-010
• MDR Report Key: 8874857
• MDR Text Key: 153718540
• Report Number: 8040288-2019-00003
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V458
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other