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

Lot Number 1543-001

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

Patient Problems Reaction (2414); Sweating (2444)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

The product was returned and is currently pending completion of the evaluation.An assessment of the event was completed by valeant medical personnel.It is unlikely that sodium bicarbonate buffer will cause such a reaction with cardiac side effects.The event is unlikely related to the product.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Patient received a lower block injection of buffered lidocaine during a dental treatment.Doctor's office reported that the patient immediately started breaking out in a cold sweat and their blood pressure went up.The patient was transported by ambulance to the hospital.Medical information relevant to the patent's hospital visit was not provided.Upon follow up the doctor reports the patient is recovered.

Manufacturer Narrative

The product was returned, however the adverse event cannot be duplicated, therefore testing was not performed.A review of the lot batch record concluded there were no observed abnormalities in the weighing, formulation, filing, and packaging steps.The batch was manufactured in accordance with all specified requirements.Based on 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; rochester NY 14609
• Manufacturer (Section G): ALLIANCE MEDICAL PRODUCTS, A SIEGFRIED COMPANY; 9342 jeronimo road; irvine CA 92618
• Manufacturer Contact: cecilia ionescu ; 50 technology drive west; irvine, CA 92618 ; 9493985697
• MDR Report Key: 6439049
• MDR Text Key: 71032585
• Report Number: 3009443653-2017-00012
• 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: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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: 10/27/2018
• Device Lot Number: 1543-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization