MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ECHELON FLEX 45 STANDARD EC45A manufactured by Ethicon Endo-surgery, Llc..
Report Number | 3005075853-2020-01890 |
MDR Report Key | 9908467 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-03-31 |
Date of Report | 2020-03-09 |
Date of Event | 2020-03-05 |
Date Mfgr Received | 2020-03-09 |
Date Added to Maude | 2020-03-31 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. KARA DITTY-BOVARD |
Manufacturer Street | 475 CALLE C |
Manufacturer City | GUAYNABO 00969 |
Manufacturer Country | * |
Manufacturer Postal | 00969 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
Manufacturer Street | 475 CALLE C |
Manufacturer City | GUAYNABO 00969 |
Manufacturer Country | * |
Manufacturer Postal Code | 00969 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ECHELON FLEX 45 STANDARD |
Generic Name | STAPLE, IMPLANTABLE |
Product Code | GDW |
Date Received | 2020-03-31 |
Model Number | EC45A |
Catalog Number | EC45A |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ETHICON ENDO-SURGERY, LLC. |
Manufacturer Address | 475 CALLE C GUAYNABO 00969 * 00969 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-31 |