MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2013-10-16 for ISOLITE SYSTEM MOUTHPIECE CIL0800 manufactured by Innerlite, Inc., Dba Isolite Systems.
[3951917]
Two weeks after normal dental procedure to replace a filling, patient experienced jaw pain and the inability to close his mouth (temporomandibular joint disorder, tmj). He reported this to the dentist who performed the dental procedure at that time. The dentist did not notify us (the mfr). The patient notified us on (b)(4) 2013. Dentist performed a standard dental procedure for a filling in a tooth of the patient. The doctor used an isolite system and isolite system mouthpiece used for retracing the tongue, keeping the mouth open with the bite block (integrated into the design of the mouthpiece, utilizing the vacuum and illumination features of the...
Patient Sequence No: 1, Text Type: D, B5
[11393300]
Patient complained to dentist of pain in jaw, 2 weeks after dental procedure (filling) using the isolite mouthpiece. Dentist referred patient to oral surgeon who diagnosed patient with tmj (temporomandibular joint) disorder. At the time, the patient file the complaint with us (mfr) he had almost fully recovered but still had some limited mobility of his jaw.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032574-2013-00001 |
| MDR Report Key | 3426510 |
| Report Source | 00,07 |
| Date Received | 2013-10-16 |
| Date of Report | 2013-10-14 |
| Date of Event | 2013-08-01 |
| Date Mfgr Received | 2013-10-07 |
| Date Added to Maude | 2013-10-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MORRIS SHERWOOD, DIRECTOR |
| Manufacturer Street | 111 CASTILIAN DR. |
| Manufacturer City | SANTA BARBARA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055609888 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLITE SYSTEM MOUTHPIECE |
| Generic Name | ISOLITE MOUTHPIECE |
| Product Code | EAY |
| Date Received | 2013-10-16 |
| Model Number | CIL0800 |
| Catalog Number | CIL0800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNERLITE, INC., DBA ISOLITE SYSTEMS |
| Manufacturer Address | 111 CASTILIAN DR. SANTA BARBARA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-16 |