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

Catalog Number V455

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

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.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us 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

A potential health professional allergic reaction to vipi flash liquid was reported by another health professional on (b)(6) 2019.The symptom experienced appears to be a form of contact dermatitis from handling of the pmma liquid.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• 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: 8395867
• MDR Text Key: 138000510
• Report Number: 8040288-2019-00002
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V455
• Device Lot Number: 97414
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other