MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. PROCLINIC ELASTICS LATEX 5/16 X 6.5OZ; BAND, ELASTIC, ORTHODONTIC

Catalog Number PC566

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.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

It was reported that a patient experienced an allergic reaction and was in the hospital after using proclinic latex elastics.No additional details are available.

Manufacturer Narrative

A dhr review was conducted with no discrepancies noted.

• Brand Name: PROCLINIC ELASTICS LATEX 5/16 X 6.5OZ
• 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: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6965355
• MDR Text Key: 89844401
• Report Number: 1036212-2017-00008
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC566
• Device Lot Number: 00066279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other