MAUDE Adverse Event Report: DENTSPLY CAULK PROBOND ALL PURPOSE TOTAL-ETCH BONDING AGENT; AGENT, TOOTH BONDING, RESIN

Catalog Number 634275

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Event Description

In this event it was reported that a pt experienced anaphylactic shock after a dental procedure where probond was used.The pt is reportedly "fine" and is having allergy testing done, the results are still pending.

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.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.

• Brand Name: PROBOND ALL PURPOSE TOTAL-ETCH BONDING AGENT
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia street, suite 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4538305
• MDR Text Key: 22030258
• Report Number: 2515379-2015-00008
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 634275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening