MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-21 for ISOLITE PEDIATRIC MOUTHPIECE CIL0501 manufactured by Innerlite, Dba Isolite Systems.
[5500463]
On (b)(6) 2015, the doctor was working on a (b)(6) patient under unconscious i. V. Sedation for fillings, pulpotomy and silver crowns. The doctor was using an isolite pediatric size mouthpiece and had packed the patients throat with cotton as per standard dental protocol. The patient chair was in a fully reclined position. Approximately 10-15 minutes from the start of the procedure the nurse anesthetist noticed that the patient was beginning to turn blue and the pulse ox monitor was dropping. She immediately alerted the doctor and they removed the mouthpiece and throat pack. The patients color and pulse returned to normal and they continued the procedure using a rubber dam with no further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032574-2015-00003 |
| MDR Report Key | 4479310 |
| Report Source | 05 |
| Date Received | 2015-01-21 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-08 |
| Date Mfgr Received | 2015-01-08 |
| Date Added to Maude | 2015-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MORRIS SHERWOOD |
| Manufacturer Street | 6868A CORTONA DR. |
| Manufacturer City | SANTA BARBARA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059689888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLITE PEDIATRIC MOUTHPIECE |
| Generic Name | PEDIATRIC MOUTHPIECE |
| Product Code | EIF |
| Date Received | 2015-01-21 |
| Model Number | CIL0501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNERLITE, DBA ISOLITE SYSTEMS |
| Manufacturer Address | 6868A CORTONA DR., SANTA BARBARA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-21 |