MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-16 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[77736515]
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.
Patient Sequence No: 1, Text Type: N, H10
[77736516]
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).
Patient Sequence No: 1, Text Type: D, B5
[96774927]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2017-00020 |
| MDR Report Key | 6646674 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-16 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-05-17 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2017-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | ALLIANCE MEDICAL PRODUCTS, A SIEGFRIED COMPANY |
| Manufacturer Street | 9342 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER |
| Generic Name | PH BUFFER |
| Product Code | JCC |
| Date Received | 2017-06-16 |
| Lot Number | 1604-029 |
| ID Number | NI |
| Device Expiration Date | 2019-01-29 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALEANT PHARMACEUTICALS INTERNATIONAL |
| Manufacturer Address | 1400 NORTH GOODMAN STREET SUITE 1 ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-16 |