MAUDE Adverse Event Report: SYBRONENDO SYBRONENDO; TF ADAPTIVE GUTTA PERCHA POINT ASST. ML1, ML2 & ML3 - 50PK

Catalog Number 815-1546

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

No patient information was provided in regards to age, sex, weight, ethnicity, and race.Patient also had a filling done at the time however no information was provided about the products used and if those un-named products had been considered an issue.The product is not available for return, no evaluation can be conducted.

Event Description

An alleged incident was reported that one female patient had an allergic reaction with a full body rash seven days after endodontic treatment with gutta percha.Patient was on clindamycin rx prior to endodontic treatment.The patient went to a medical doctor and the diagnosis was that she was allergic to gutta percha and not the clindamycin.It was reported that patient would require an extraction due to an issue the doctor did not want to disclose.The same patient had 2 other endodontic procedures done previously without issue with the same products.Patient still has the rash and has been prescribed steroid creams.

• Brand Name: SYBRONENDO
• Type of Device: TF ADAPTIVE GUTTA PERCHA POINT ASST. ML1, ML2 & ML3 - 50PK
• Manufacturer (Section D): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): SYRBONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, CA 92867
• MDR Report Key: 7599577
• MDR Text Key: 111000707
• Report Number: 2016150-2018-00020
• Device Sequence Number: 1
• Product Code: EKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 815-1546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other