MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for THORACIC CATHETER REF # 8132 manufactured by Atrium Medical Corporation.
Report Number | MW5090324 |
MDR Report Key | 9174685 |
Date Received | 2019-10-09 |
Date of Report | 2019-10-08 |
Date of Event | 2019-09-18 |
Date Added to Maude | 2019-10-10 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | THORACIC CATHETER |
Generic Name | CATHETER, CHOLANGIOGRAPHY |
Product Code | GBZ |
Date Received | 2019-10-09 |
Catalog Number | REF # 8132 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ATRIUM MEDICAL CORPORATION |
Manufacturer Address | HUDSON NH 03051 US 03051 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-09 |