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 2020-03-05 for FBK DUAL INC. W/O TROCAR 8/PK 006889-901 manufactured by Gyrus Acmi, Inc.
Report Number | 2951238-2020-00354 |
MDR Report Key | 9793835 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-05 |
Date of Report | 2020-03-27 |
Date Mfgr Received | 2020-03-26 |
Device Manufacturer Date | 2018-02-28 |
Date Added to Maude | 2020-03-05 |
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 | MS. CONNIE TUBERA |
Manufacturer Street | 2400 RINGWOOD AVENUE |
Manufacturer City | SAN JOSE CA 95131 |
Manufacturer Country | US |
Manufacturer Postal | 95131 |
Manufacturer Phone | 4089355124 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FBK DUAL INC. W/O TROCAR 8/PK |
Generic Name | DISPOSABLE FALOPE-RING BAND |
Product Code | KNH |
Date Received | 2020-03-05 |
Returned To Mfg | 2020-02-18 |
Model Number | 006889-901 |
Lot Number | MK735611 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | GYRUS ACMI, INC |
Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-05 |