MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-10 for GOWN, SURGICAL PACK 123688D COMPONENT 7005 manufactured by Novo Health Services.
| Report Number | 1000306225-2020-00002 |
| MDR Report Key | 9690142 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ZILLERY FORTNER |
| Manufacturer Street | 7086 INDUSTRIAL ROW DRIVE |
| Manufacturer City | MASON, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3986406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOWN, SURGICAL |
| Generic Name | REUSABLE SURGICAL GOWN |
| Product Code | FYA |
| Date Received | 2020-02-10 |
| Model Number | PACK 123688D COMPONENT 7005 |
| Catalog Number | PACK 123688D COMPONENT 7005 |
| Lot Number | 219568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES |
| Manufacturer Address | 6024 CENTURY OAKS DR CHATTANOOGA, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |