MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-04 for GOWN, SURGICAL L2 700* manufactured by Novo Health Services, Llc.
Report Number | 1000306225-2020-00001 |
MDR Report Key | 9666001 |
Report Source | USER FACILITY |
Date Received | 2020-02-04 |
Date of Report | 2020-01-30 |
Date of Event | 2020-01-14 |
Date Mfgr Received | 2020-01-20 |
Date Added to Maude | 2020-02-04 |
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. ZILLERY FORTNER |
Manufacturer Street | 1416 DOGWOOD WAY |
Manufacturer City | MEBAN NC 27302 |
Manufacturer Country | US |
Manufacturer Postal | 27302 |
Manufacturer Phone | 5133986406 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GOWN, SURGICAL L2 |
Generic Name | REUSABLE SURGICAL GOWN |
Product Code | FYA |
Date Received | 2020-02-04 |
Model Number | 700* |
Catalog Number | 700* |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NOVO HEALTH SERVICES, LLC |
Manufacturer Address | 1416 DOGWOOD WAY MEBANE NC 27302 US 27302 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-04 |