MAUDE Adverse Event Report: KERR CORPORATION OPTIBOND XTR; RESIN TOOTH BONDING AGENT

Catalog Number 35107

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Respiratory Distress (2045); Reaction (2414)

Event Type  Injury  

Event Description

A patient alleged that she had experienced a reaction of respiratory issues after placement with optibond xtr primer.

Manufacturer Narrative

The patient refused to provide her doctor's information and the type of treatment that she had received.It was reported that she has visited two (2) doctors who had informed her that she had some type of toxicological reaction resulting in a neuromuscular condition.She is currently undergoing a detoxification process.Ra will update this complaint if additional information becomes available.The product was not returned and no lot number was provided; therefore, no evaluations can be conducted.

• Brand Name: OPTIBOND XTR
• Type of Device: RESIN TOOTH BONDING AGENT
• Manufacturer (Section D): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4281292
• MDR Text Key: 15998184
• Report Number: 2024312-2014-00666
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K101423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2014

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?: No
• Device Operator: Dentist
• Device Catalogue Number: 35107
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention