MAUDE Adverse Event Report: DENTSPLY CAULK PRIME & BOND NT; AGENT TOOTH BONDING, RESIN

Catalog Number 634352

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

In this event a dentist reported that a patient had experienced an allergic reaction after using several dentsply products.The dentist stated that a dental impression was taken with jeltrate chroma three weeks earlier and the patient did well.The patient returned for a crown and bridge three weeks after having the impression taken.During this appointment tph spectra and prime and bond nt were used, among other non-dentsply products.The next day the patient's lips became swollen and white.The patient took an otc allergy medicine to combat the reaction.The day after taking the medication, the patient woke up and her lips were swollen worse than the day before, so she took more otc allergy medicine.At 4 o'clock that day the patient contacted her dentist because her symptoms did not get better.The dentist directed her to seek medical attention.The patient went to the er, where they administered prednisone.The systems abated after receiving the prednisone.

Manufacturer Narrative

While it is unknown if the devices 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.

• Brand Name: PRIME & BOND NT
• Type of Device: AGENT TOOTH BONDING, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4017566
• MDR Text Key: 16188517
• Report Number: 2515379-2014-00046
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 634352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention