MAUDE Adverse Event Report: DENTSPLY CAULK LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER; RESIN, DENTURE, RELINING, REPAIRING, REBASING

Catalog Number 653006

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/13/2015

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.

Event Description

In this event it was reported that on (b)(6) 2015 a dentist used lynal to reline a denture for a male patient.On (b)(6) 2015 the patient contacted the dentist stating that he could not wear the dentures, the taste was "horrible".On (b)(6) 2015 the patient contacted the dentist and stated he stopped wearing the dentures because his mouth was too sore.The dentist then had the patient come into his office.The dentist reported that both the maxillary and mandibular of the patient were broke out with ulcers, the mandibular arch was the worse.The dentist stated he removed the lynal and had the patient rinse with salt water.The patient was seen again on (b)(6) 2015 and the ulcers were clear.

• Brand Name: LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASING
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5022406
• MDR Text Key: 23749564
• Report Number: 2515379-2015-00050
• 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
• Report Date: 07/22/2015

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: 653006
• Device Lot Number: 150701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other