MAUDE Adverse Event Report: DENTSPLY RAINTREE ESSIX GLENROE DENTAURUM TIES; BAND, ELASTIC, ORTHODONTIC

Catalog Number DENT-2SIL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that after the use of elastic ligature ties, a pt had an allergic reaction.Further details of the symptoms and event are not available.

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the pt'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.Reportability per 21 cfr part 803.The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: DENTAURUM TIES
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• Manufacturer (Section D): DENTSPLY RAINTREE ESSIX GLENROE; sarasota FL 34243
• Manufacturer Contact: helen lewis ; 221 w philadelphia st; ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3732979
• MDR Text Key: 20655806
• Report Number: 3009683512-2014-00001
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DENT-2SIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other