MAUDE Adverse Event Report: DENTSPLY CAULK LYNAL

Catalog Number 653006

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Type  Injury  

Event Description

In this event it was reported that a pt developed ulcers after the use of lynal.The pt's symptoms subsided one week after the lynal was removed.

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 eval, though has not been returned as of this report.Eval results will be submitted as they become available.

• Brand Name: LYNAL
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer (Section G): DENTSPLY CAULK; 38 w clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste 60; susquehanna commerce center w; york, PA 17401 ; 7178457511
• MDR Report Key: 3644261
• MDR Text Key: 21048960
• Report Number: 2515379-2014-00005
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 653006
• Device Lot Number: 130725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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