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 Problem Numbness (2415)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

The product was not available for return.An assessment of the event was completed by valeant medical personnel.While this is a serious event, temporary paresthesia is a common complication of dental treatment with anesthesia and usually resolves, especially in cases such as this where there is visible resolution in a short period of time.The event is possibly related to the product.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Doctor reported a patient experienced numbness three days after a dental treatment.Doctor reported patient has a history of cancer and presented with a healed canker sore at the time of treatment.Patient received one infiltration of one carpule of buffered septocaine dialed to 8, in the lip and nasal area.After treatment, patient felt the anesthesia was wearing off.Patient returned three days later for additional dental treatment, and reported still having numbness in the nasal and lip area.Doctor gave patient vitamin b supplement and zinc per the advice of an oral surgeon.Doctor prescribed a medrol dose pack and the patient informed her that they did not want to continue taking it after a few pills.The doctor thinks the patient did not take the medication at all.The patient is taking naproxen (anti-inflammatory) for a different condition and wanted to take that instead of the anti-inflammatory the doctor wanted to prescribe.Doctor reported the numbness is getting smaller and patient states she is getting better.It is unknown if the patient is still taking the vitamin b supplement or zinc.Patient did not return for follow-up visit and has not contacted the office.Doctor thinks the patient may have recovered as they have not heard from her.

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 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: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 6135896
• MDR Text Key: 61140653
• Report Number: 3009443653-2016-00040
• 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: 10/31/2016

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: 10/27/2018
• Device Lot Number: 1543-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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
• Patient Age: 49 YR