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 Problems Twitching (2172); Numbness (2415)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

The product is not available for return and the lot number was not reported.The doctor thinks the event may be related to an allergy to the local anesthetic.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor reported a patient received an infiltration and two days after the dental procedure, the patient experienced paresthesia of the lips, nose and chin area.During dental treatment the doctor buffered with septocaine and the pen was dialed to 18.Doctor reported patient has paresthesia and twitching of the upper lip but all other paresthesia has resolved.The patient visited a neurologist and an allergist.The allergist treated the patient with a medrol dose pack and an antibiotic.The paresthesia is resolving.The doctor thinks the event may be related to an allergy to the local anesthetic.

Manufacturer Narrative

The product was not returned and the lot number was not reported.The manufacturer's investigation identified no causal factors 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: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 6113284
• MDR Text Key: 60356366
• Report Number: 3009443653-2016-00037
• 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,Followup
• Report Date: 10/20/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention