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

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

Patient Problem Muscle Spasm(s) (1966)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

An assessment of the event was completed by valeant medical personnel.It is unlikely that the device is the cause of the event but there is no other pertinent information available to determine the causality.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

It was reported a doctor had a few patients who complained of trismus.The doctor prescribed a muscle relaxer and indicated the events were not "too serious".Additional information was requested from the doctor but no response has been received.

• 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: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 6572315
• MDR Text Key: 75343857
• Report Number: 3009443653-2017-00018
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other