MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-29 for ONSET SODIUM BICARBONATE 8.4% STERILE PH BUFFER manufactured by Valeant Pharmaceuticals International.
[44041875]
The device was discarded. An assessment of the case was completed by valeant medical personnel. Usually teeth not coming together, after a dental visit is due to straining the tmj during the visit from opening the jaw for a prolonged period of time, or inflammation around the tmj. This is possibly related to needle trauma unlikely related to the device. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[44041877]
A dentist reported a patient received a mandibular block and long buccal injection by gow gaites technique of septocaine buffered with onset dialed to 18 on tooth #19. Twelve days later, the patient reported pain at the injection site and swelling in the retromolar left area and in the left cheek area but the doctor stated the area was not visibly swollen. Patient was placed on a medrol dose pack, given 2 tablets of amoxicillin and referred to a periodontist. No infection was present so an antibiotic was not fully prescribed. The doctor made the patient a splint to keep her teeth apart. A follow-up was made with the patient who works at the dental office. The patient finished the medrol dose pack and started neproxin, an anti-inflammatory and robaxin, a muscle relaxant. At this time, she is no longer taking the medications but is still using the splint every night. Her back teeth are still not together and it is tight but there is no pain. She is using her front teeth when biting and chewing and is slowly getting back to normal.
Patient Sequence No: 1, Text Type: D, B5
[46019312]
Patient Sequence No: 1, Text Type: N, H10
[46019313]
Patient followed-up to inform that she is recovered.
Patient Sequence No: 1, Text Type: D, B5
[61800154]
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 to product specification. 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 | 3009443653-2016-00006 |
| MDR Report Key | 5619987 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-11 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2015-08-12 |
| Date Added to Maude | 2016-04-29 |
| 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 | 2016-04-29 |
| Lot Number | 1530-002 |
| ID Number | NI |
| Device Expiration Date | 2018-08-12 |
| 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 | 2016-04-29 |