MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-09-19 for ISODRY SYSTEM AND MOUTHPIECE EID0101/CILXX01 manufactured by Innerlite Systems.
[4870095]
Doctor did not report this to isolite systems until (b)(6) 2014 (5 months past event) - (b)(6) female cancer pt received dental crown preparation/fillings from dentist in (b)(6) (using an isodry system and mouthpiece). Pt was treated without incident. Pt went home and died the following week.
Patient Sequence No: 1, Text Type: D, B5
[12363330]
The doctor saw the pt in (b)(6). Her appointment was for crown prep on two teeth (#14 and 15 left side of the mouth). The pt was diagnosed and treated for head and neck cancer in 2008 (right side of the mouth) and had radiation treatment. The doctor stated he seated the pt and placed a mouthpiece and began prep of the first tooth. He was finished within 30-40 minutes then had her take a break while he prepared for the second prep. She was able to get up and move around, say hello to staff members, then after 15-20 minutes came back to the chair for further treatment. He was done with both crown preps within 2 hours. The doctor was contacted the following tuesday after the appointment. He stated he was told by the pt's daughter that she had been complaining of sore throat and feeling hoarse after her dental appointment. Pt was almost (b)(6) at the time of her death. Although she seemed to be doing well, she had a long history of cancer and heart disease (had a triple bypass). The death is being attributed to pneumonia. The pt was never seen at the hospital, she died at home in her bed. The doctor said the family had the pt cremated within two weeks and no autopsy was completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032574-2014-00002 |
| MDR Report Key | 4168316 |
| Report Source | 99 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-04-15 |
| Date Mfgr Received | 2014-09-04 |
| Date Added to Maude | 2014-10-15 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISODRY SYSTEM AND MOUTHPIECE |
| Generic Name | ISODRY SYSTEM |
| Product Code | EIF |
| Date Received | 2014-09-19 |
| Model Number | EID0101/CILXX01 |
| Catalog Number | EID0101/CILXX01 |
| 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 SYSTEMS |
| Manufacturer Address | 6868A CORTONA DR SANTA BARBARA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-09-19 |