MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-11 for SYMMETRY 63-4031 manufactured by Symmetry Surgical, Inc.
Report Number | 3007208013-2020-00004 |
MDR Report Key | 9695914 |
Report Source | USER FACILITY |
Date Received | 2020-02-11 |
Date of Report | 2020-02-11 |
Date of Event | 2020-01-08 |
Date Mfgr Received | 2020-01-15 |
Device Manufacturer Date | 2016-02-05 |
Date Added to Maude | 2020-02-11 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | BRANDI MEATH |
Manufacturer Street | 3034 OWEN DRIVE |
Manufacturer City | ANTIOCH, TN |
Manufacturer Country | US |
Manufacturer Phone | 9645290 |
Manufacturer G1 | SYMMETRY SURGICAL INC |
Manufacturer Street | 3034 OWEN DRIVE |
Manufacturer City | ANTIOCH, TN |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SYMMETRY |
Generic Name | VEIN STRIPPER |
Product Code | GAJ |
Date Received | 2020-02-11 |
Catalog Number | 63-4031 |
Lot Number | 228469 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SYMMETRY SURGICAL, INC |
Manufacturer Address | 3034 OWEN DRIVE ANTIOCH, TN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-02-11 |