MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-13 for SECUREMENTS 37449 manufactured by Convatec Inc.
Report Number | 1049092-2020-00085 |
MDR Report Key | 9708485 |
Report Source | CONSUMER,FOREIGN |
Date Received | 2020-02-13 |
Date Mfgr Received | 2020-01-31 |
Date Added to Maude | 2020-02-13 |
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 | MS. JEANETTE JOHNSON |
Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
Manufacturer City | GREENSBORO NC 27409 |
Manufacturer Country | US |
Manufacturer Postal | 27409 |
Manufacturer Phone | 3365424681 |
Manufacturer G1 | CONVATEC INC |
Manufacturer Street | 211 AMERICAN AVENUE |
Manufacturer City | GREENSBORO NC 27409 |
Manufacturer Country | US |
Manufacturer Postal Code | 27409 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SECUREMENTS |
Generic Name | ACCESSORIES, CATHETER |
Product Code | KGZ |
Date Received | 2020-02-13 |
Model Number | 37449 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CONVATEC INC |
Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-13 |