MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-07-14 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Bausch + Lomb.
[49562705]
The device is not available for return. An assessment of the case was completed by valeant medical personnel. Temporary paresthesia is a common complication of dental treatment, possibly from the local anesthetic, dental treatment or injection. The paresthesia is decreasing, which suggests it will continue to resolve. 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 information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[49562706]
A dentist reported a patient was still experiencing numbness on the lateral border of her tongue one day after dental treatment. Doctor instructed patient to take ibuprofen for inflammation. The numbness was decreasing and currently there is no change to the patient's status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2016-00012 |
| MDR Report Key | 5795183 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-14 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-06-23 |
| Date Mfgr Received | 2016-06-24 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2016-07-14 |
| 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 | 50 TECHNOLOGY DRIVE WEST |
| 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 | 2016-07-14 |
| Lot Number | 1541-060 |
| ID Number | NI |
| Device Expiration Date | 2018-10-20 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-14 |