MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-30 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[61140653]
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.
Patient Sequence No: 1, Text Type: N, H10
[61140654]
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.
Patient Sequence No: 1, Text Type: D, B5
[62828852]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2016-00040 |
| MDR Report Key | 6135896 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-30 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2015-10-27 |
| Date Added to Maude | 2016-11-30 |
| 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 | 2016-11-30 |
| Lot Number | 1543-001 |
| ID Number | NI |
| Device Expiration Date | 2018-10-27 |
| 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 | 2016-11-30 |