MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for QUADRA ASSURA MP ICD CD3371-40Q manufactured by Abbott.
Report Number | 2938836-2019-16720 |
MDR Report Key | 9384675 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-27 |
Date of Report | 2019-11-27 |
Date of Event | 2019-11-16 |
Date Mfgr Received | 2019-11-18 |
Device Manufacturer Date | 2013-09-10 |
Date Added to Maude | 2019-11-27 |
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 | ELIZABETH BOLTZ |
Manufacturer Street | 15900 VALLEY VIEW COURT |
Manufacturer City | SYLMAR CA 91342 |
Manufacturer Country | US |
Manufacturer Postal | 91342 |
Manufacturer G1 | ABBOTT |
Manufacturer Street | 645 ALMANOR AVENUE |
Manufacturer City | SUNNYVALE CA 94085 |
Manufacturer Country | US |
Manufacturer Postal Code | 94085 |
Single Use | 3 |
Remedial Action | RC |
Previous Use Code | 3 |
Removal Correction Number | Z-0004-2018 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | QUADRA ASSURA MP ICD |
Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Product Code | NIK |
Date Received | 2019-11-27 |
Model Number | CD3371-40Q |
Lot Number | 4242198 |
Device Expiration Date | 2015-09-30 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ABBOTT |
Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-27 |