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

Catalog Number ESR1000

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 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.A dhr review was conducted with no discrepancies noted.

Event Description

A patient had a severe allergic reaction following placement of separators placed between his teeth today.The separators were immediately removed.

• Brand Name: RADIOPAQUE CUT SEPARATOR
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11073342
• MDR Text Key: 227719392
• Report Number: 1036212-2020-00004
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ESR1000
• Device Lot Number: 00149568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR