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 Inflammation (1932); Numbness (2415)

Event Date 06/23/2016

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 decreasing, which suggests 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 a patient was still experiencing numbness on the lateral border of her tongue one day after dental treatment.Doctor instructed patient to take ibuprofen for inflammation.The numbness was decreasing and currently there is no change to the patient's 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; 50 technology drive west; irvine CA 92618
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5795183
• MDR Text Key: 49562705
• Report Number: 3009443653-2016-00012
• 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: 06/24/2016

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: 06/24/2016
• 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