MAUDE Adverse Event Report: BAUSCH + LOMB ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER

Lot Number 1541-060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); Numbness (2415)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The device is not available for return.An assessment of the case was completed by valeant medical personnel.Temporary paresthesia is a common complication of dental treatment, possibly from the local anesthetic, dental treatment or injection.The paresthesia is resolving which in most cases, dictates it will continue to resolve.A review of the manufacturing records concluded there were no observed abnormalities and the batch was manufactured in accordance with all specified requirements.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A dentist reported that five days after dental treatment, a patient had burning and numbness on the left side of the tongue as well as numbness of the left mandibular gingiva.During the dental treatment, the doctor administered 2 injections of lidocaine with epi 1:100,000 for a fractured tooth #17 for a restoration.Injections were inferior alveolar nerve block (ianb), lingual and long buccal.The dentist prescribed medrol dose pack and pain medication, norco 325.The patient completed the medrol dose pack and stopped the pain medication as the burning tongue resolved.The paresthesia is resolving.The tip of patient's tongue is no longer numb and the burning has resolved.At this time, there has been no change in patient status.

• Brand Name: ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER
• Type of Device: PH BUFFER
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ALLIANCE MEDICAL PRODUCTS, A SIEGFRIED COMPANY; 9342 jeronimo road; irvine CA 92618
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5795031
• MDR Text Key: 49559724
• Report Number: 3009443653-2016-00011
• Device Sequence Number: 1
• Product Code: JCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/16/2016

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 Expiration Date: 10/20/2018
• Device Lot Number: 1541-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR