MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-28 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[71032585]
The product was returned and is currently pending completion of the evaluation. An assessment of the event was completed by valeant medical personnel. It is unlikely that sodium bicarbonate buffer will cause such a reaction with cardiac side effects. The event is unlikely related to the product. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[71032586]
Patient received a lower block injection of buffered lidocaine during a dental treatment. Doctor's office reported that the patient immediately started breaking out in a cold sweat and their blood pressure went up. The patient was transported by ambulance to the hospital. Medical information relevant to the patent's hospital visit was not provided. Upon follow up the doctor reports the patient is recovered.
Patient Sequence No: 1, Text Type: D, B5
[108004992]
The product was returned, however the adverse event cannot be duplicated, therefore testing was not performed. 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 | 3009443653-2017-00012 |
| MDR Report Key | 6439049 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-03-28 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CECILIA IONESCU |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985697 |
| 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 | 2017-03-28 |
| Returned To Mfg | 2017-03-23 |
| Lot Number | 1543-001 |
| ID Number | NI |
| Device Expiration Date | 2018-10-27 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2017-03-28 |