MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-09 for ISOVAC ADAPTER & MOUTHPIECE CIL0900 CIL 0900 manufactured by Innerlite, Inc. Dba Isolite Systems.
[20658106]
Dentist performed 15 minute dental filling procedure on the pt using the isovac device (part number eiv0101) and large mouthpiece (part number cil0900) to isolate the portion of the mouth being worked on. Immediately after treatment pt complained of swelling under the tongue. The doctor confirmed that tissue was swollen. The doctor stated he erroneously used too large a mouthpiece. Doctor stated that pt appeared to have a traumatized salivary gland near the ranula. Doctor said that treatment and initial event occurred in (b)(6). The doctor did not notify isolite systems until (b)(4) 2014. The doctor also stated that the swelling lasted four weeks and that the pt was going to be referred to an oral surgeon. Subsequent attempts to contact the doctor to get status update have not been successful (doctor not responding to voice male/female).
Patient Sequence No: 1, Text Type: D, B5
[20945855]
Since the device was not returned to the manufacturer, solite systems does not have enough info to determine the root cause of this issue. As such, based on the info provided and review of all post marketing surveillance info to date, isolite systems does not see a causal relationship between the isovac/mouthpiece and the pt symptoms reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032574-2014-00001 |
| MDR Report Key | 4181345 |
| Report Source | 05 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-09-02 |
| Date of Event | 2014-07-26 |
| Date Mfgr Received | 2014-08-26 |
| Date Added to Maude | 2014-10-20 |
| 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 | ISOVAC ADAPTER & MOUTHPIECE |
| Generic Name | ISOVAC MOUTHPIECE |
| Product Code | EIF |
| Date Received | 2014-09-09 |
| Model Number | CIL0900 |
| Catalog Number | CIL 0900 |
| 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, INC. 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 | 2014-09-09 |