MAUDE Adverse Event Report: STICK TECH LTD. EVERSTICK; EVERSTICK ORTHO

Model Number 44786

Device Problem Inaccurate Dispensing (2955)

Patient Problem Discomfort (2330)

Event Date 11/10/2015

Event Type  Injury  

Event Description

A female patient alleged to have suffered severe pain after splinting treatment of a dental element with the above mentioned product (splinting fiber), used in conjunction with an adhesive from another manufacturer (transbond supreme, 3m, lot not available).The reaction consisted in pain, mouth dryness, altered taste and altered saliva consistency, taste of glue in the mouth.Patient has asked the doctor the re-treatment of the splinting, and after under-gengiva excess adhesive removal, has been redirected to another doctor.It is unclear if the patient has contacted further professionals ad if she has been subject to further therapy.Dentist advised to consult an allergologist.

• Brand Name: EVERSTICK
• Type of Device: EVERSTICK ORTHO
• Manufacturer (Section D): STICK TECH LTD.; lemminkaisenkatu 46; turku lansi-suomen laani, FI-20 521; FI FI-20521
• MDR Report Key: 5412592
• MDR Text Key: 37543363
• Report Number: 1410097-2016-00001
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/04/2017
• Device Model Number: 44786
• Device Catalogue Number: 900831
• Device Lot Number: 20150204A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2016
• Distributor Facility Aware Date: 01/15/2016
• Event Location: Other
• Date Report to Manufacturer: 02/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TRANSBOND SUPREME
• Patient Outcome(s): Other
• Patient Age: 51 YR