MAUDE Adverse Event Report: DENTSPLY PROSTHETICS BIOFORM IPN PLASTIC TEETH (20° POSTERIORS); DENTURE, PLASTIC, TEETH

Catalog Number 16686

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

The patient has declined to return the sample for investigation at this time.While it is unknown if the device used in this case caused or contributed to the patient'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.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

It was reported that a patient experienced an allergic reaction with symptoms including swelling of the tongue one hour after insertion of a removable lower partial denture fabricated with bioform ipn teeth and valplast resin (competitive product).The patient was treated for symptoms in the er and symptoms alleviated once the device was removed from the mouth for 24 hours.

• Brand Name: BIOFORM IPN PLASTIC TEETH (20° POSTERIORS)
• Type of Device: DENTURE, PLASTIC, TEETH
• Manufacturer (Section D): DENTSPLY PROSTHETICS; 570 west college avenue; york PA 17404
• Manufacturer (Section G): DENTSPLY PROSTHETICS; 570 west college avenue; york PA 17404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7444222
• MDR Text Key: 105960710
• Report Number: 2585114-2018-00001
• Device Sequence Number: 1
• Product Code: ELM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792245
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VALPLAST RESIN
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR