MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-21 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[50082404]
The device was not returned. An assessment of the event was completed by valeant medical personnel. The dentist used articaine which is not off label, however valeant medical personnel recommended the dentist only use lidocaine with epinephrine. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[50082505]
Dentist reported patient had an infiltration on the mandibular lower left bicuspid. Articane 4% with 1:100 epinephrine was administered. Patient developed advanced necrosis with pain, fever and significant tissue sloughing. Patient was treated with kenalog in orabase and augmentin 500 mg and symptoms took weeks to resolve.
Patient Sequence No: 1, Text Type: D, B5
[61786745]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2016-00013 |
| MDR Report Key | 5811807 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-04-12 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2015-08-12 |
| Date Added to Maude | 2016-07-21 |
| 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. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| 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 | 2016-07-21 |
| Lot Number | 1530-002 |
| ID Number | NI |
| Device Expiration Date | 2018-08-12 |
| 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 | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-21 |