MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-22 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.
Report Number | 1721279-2019-00205 |
MDR Report Key | 9365879 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-11-22 |
Date of Report | 2019-11-07 |
Date of Event | 2019-11-05 |
Report Date | 2005-01-01 |
Date Reported to FDA | 2005-01-01 |
Date Reported to Mfgr | 2005-01-10 |
Date Mfgr Received | 2019-11-07 |
Date Added to Maude | 2019-11-22 |
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. BARBARA CREEL |
Manufacturer Street | 9965 FEDERAL DRIVE |
Manufacturer City | COLORADO SPRINGS CO 80921 |
Manufacturer Country | US |
Manufacturer Postal | 80921 |
Manufacturer Phone | 719447-246 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SPECTRANETICS 16F GLIDELIGHT LASER SHEATH |
Generic Name | GLIDELIGHT |
Product Code | MFA |
Date Received | 2019-11-22 |
Model Number | 500-303 |
Catalog Number | 500-303 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | THE SPECTRANETICS CORPORATION |
Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-11-22 |