MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for SILICONE CATHETERS 14228 manufactured by Atrium Medical Corporation.
[186839991]
A follow up report will be submitted upon the completion of the investigation into this event.
Patient Sequence No: 1, Text Type: N, H10
[186839992]
Hospital reported that the chest x-ray did not show radiopaque line on the catheter.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011175548-2020-00332 |
MDR Report Key | 9767171 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-02-27 |
Date of Report | 2020-02-27 |
Date Mfgr Received | 2020-02-25 |
Date Added to Maude | 2020-02-27 |
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 Street | 40 CONTINENTAL BLVD |
Manufacturer City | MERRIMACK NH 03054 |
Manufacturer Country | US |
Manufacturer Postal | 03054 |
Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
Manufacturer Street | 40 CONTINENTAL BLVD |
Manufacturer City | MERRIMACK NH 03054 |
Manufacturer Country | US |
Manufacturer Postal Code | 03054 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SILICONE CATHETERS |
Generic Name | CATHETER, CHOLANGIOGRAPHY |
Product Code | GBZ |
Date Received | 2020-02-27 |
Model Number | 14228 |
Catalog Number | 14228 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ATRIUM MEDICAL CORPORATION |
Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-27 |