MAUDE Adverse Event Report: VALEANT PHARMACEUTICALS INTERNATIONAL ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER

Lot Number 1604-029

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Numbness (2415)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

An assessment of the event was completed by valeant medical personnel.There is insufficient information to help determine the causality of the event.It is possible that the device is the cause of the event.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Doctor reported a patient experienced pain and numbing of the cheek after dental treatment.The pain was experienced when chewing or opening their jaw.The doctor administered lidocaine 2% 1 to 100,000 epinephrine for a mandibular block treatment.The pen was dialed to 17.Patient experienced the symptoms on the same day as the dental treatment when the local anesthetic wore off.Doctor reported no signs of infection.Patient was treated with ibuprofen 4 times a day for 14 days and instructed to apply a heating pad to the affected area.Upon follow-up, the patient informed the doctor that the numbness in the cheek is almost completely gone.The duration of the numbness lasted about one month.The patient described the current discomfort as being completely located in the temporomandibular joint.The patient has no pain except when she opens wide.The doctor referred the patient to a colleague who works primary with tmd (temporomandibular joint disorder).

Manufacturer Narrative

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 available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER
• Type of Device: PH BUFFER
• Manufacturer (Section D): VALEANT PHARMACEUTICALS INTERNATIONAL; 1400 north goodman street; suite 1; rochester NY 14609
• Manufacturer (Section G): ALLIANCE MEDICAL PRODUCTS, A SIEGFRIED COMPANY; 9342 jeronimo road; irvine CA 92618
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 6646674
• MDR Text Key: 77736515
• Report Number: 3009443653-2017-00020
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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: 01/29/2019
• Device Lot Number: 1604-029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 05/17/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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): Other