MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for ISOLITE MOUTHPIECE. CIL0801 manufactured by Zyris, Inc..
| Report Number | 2032574-2019-00001 |
| MDR Report Key | 9182945 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-10-11 |
| 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 | ZYRIS, INC. |
| 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 | ISOLITE MOUTHPIECE, MEDIUM DV CIL0801 |
| Product Code | EIF |
| Date Received | 2019-10-11 |
| Model Number | CIL0801 |
| Catalog Number | CIL0801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYRIS, INC. |
| Manufacturer Address | 6868A CORTONA DRIVE SANTA BARBARA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-11 |