MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for ISOLITE MOUTHPIECE CIL0601 manufactured by Innerlite, Inc..
[30329345]
Complaint received via phone from dentist. Device disposed of by dentist. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[30329346]
Dentist was performing 2 hour crown preparation using the isolite mouthpiece (size: small). Patient jaw locked open during the procedure. Patient has a history of tmj (temporal mandibular joint disorder). Physician diagnosis was jaw disarticulation (post procedure) which require surgery the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032574-2015-00004 |
| MDR Report Key | 5199238 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-09-30 |
| Date Mfgr Received | 2015-09-18 |
| Date Added to Maude | 2015-11-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MORRIS SHERWOOD |
| Manufacturer Street | 6868A CORTONA DR. |
| Manufacturer City | SANTA BARBARA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055609888 |
| Manufacturer G1 | ISOLITE SYSTEMS |
| Manufacturer Street | 6868A CORTONA DR. |
| Manufacturer City | SANTA BARBARA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISOLITE MOUTHPIECE |
| Generic Name | MOUTHPIECE (SMALL) |
| Product Code | DYN |
| Date Received | 2015-11-03 |
| Model Number | CIL0601 |
| Catalog Number | CIL0601 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNERLITE, INC. |
| Manufacturer Address | 6868A CORTONA DR. SANTA BARBARA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-03 |