MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-11 for REN? GEL, 1.5CC 08-015-00-V04 manufactured by Cytophil, Inc..
Report Number | 3007225376-2020-00002 |
MDR Report Key | 9820853 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-11 |
Date of Report | 2020-03-19 |
Date of Event | 2020-02-07 |
Date Mfgr Received | 2020-02-10 |
Date Added to Maude | 2020-03-11 |
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 | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. KRISTIE SOTO |
Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
Manufacturer City | EAST TROY, WI |
Manufacturer Country | US |
Manufacturer Phone | 64227656 |
Manufacturer G1 | CYTOPHIL, INC. |
Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
Manufacturer City | EAST TROY, WI |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | REN? GEL, 1.5CC |
Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION, PRODUCT CODE: MIX |
Product Code | MIX |
Date Received | 2020-03-11 |
Model Number | 08-015-00-V04 |
Catalog Number | 08-015-00-V04 |
Lot Number | U908-00100 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CYTOPHIL, INC. |
Manufacturer Address | 2485 CORPORATE CIRCLE SUITE 2 EAST TROY, WI US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-11 |