MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. LARGE BLUE SEPARATOR; BAND, ELASTIC, ORTHODONTIC

Catalog Number ESL1000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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 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 patient had separators fitted and had gone home when she developed an allergic reaction.Her face and throat started to swell.She was admitted to (b)(6) hospital where they put her on steroids and removed the separators.She is ok now and out of the hospital.

Manufacturer Narrative

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

• Brand Name: LARGE BLUE SEPARATOR
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• MDR Report Key: 7167490
• MDR Text Key: 96476685
• Report Number: 1036212-2017-00011
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ESL1000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention