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 2016-10-28 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[58655241]
The product is not available for return and the lot number was not reported. An assessment of the event was completed by valeant medical personnel. The event is possibly related to the product but could also be by vasoconstriction from epinephrine in a pdl injection. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[58655242]
A dentist reported when he used the pen alongside a wand, the patient experienced tissue necrosis. It was a single tooth anesthesia pdl with wand technique. The pen was dialed to either 18 or 9 and lidocaine was used as a buffer. He states they would sometimes use dental vibes with the onset and wand. It is unknown if the patient experienced the necrosis immediately or after a couple days. There is no sign of infection. No medical intervention was necessary but the dentist states that it takes time to heal and may be up to a year before the tissues grow back. This report is for patient 3.
Patient Sequence No: 1, Text Type: D, B5
[61912889]
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 | 3009443653-2016-00033 |
| MDR Report Key | 6063428 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-28 |
| Date of Report | 2016-09-29 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-10-28 |
| 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 | 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 | 2016-10-28 |
| 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 | 2016-10-28 |