MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[35527666]
The product was not available for return. There is a possibility the event is related to the product. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[35527667]
A dental office reported a patient received a maxillary buccal infiltration injection of lidocaine buffered to 18 for treatment of tooth #7. The patient had swelling, bruising and trouble breathing through her nose because of swelling on the right nostril. There was no respiratory distress. The symptoms resolved in 3 days without treatment or any other intervention.
Patient Sequence No: 1, Text Type: D, B5
[61646649]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2016-00001 |
| MDR Report Key | 5354855 |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-01-08 |
| 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 | 2016-01-08 |
| ID Number | NI |
| 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. Other | 2016-01-08 |