MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2003-07-02 for HR-2615 manufactured by Western/scott Fetzer Co..
| Report Number | 1526809-2003-00005 |
| MDR Report Key | 475051 |
| Report Source | 05,06,08 |
| Date Received | 2003-07-02 |
| Date of Event | 2002-07-01 |
| Date Mfgr Received | 2003-06-03 |
| Device Manufacturer Date | 1998-11-01 |
| Date Added to Maude | 2003-08-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR DINO IANIRO |
| Manufacturer Street | 875 BASSETT ROAD |
| Manufacturer City | WESTLAKE OH 441451142 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451142 |
| Manufacturer Phone | 4408712160 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HR-2615 |
| Generic Name | OXYGEN FLOW REGULATOR |
| Product Code | CCN |
| Date Received | 2003-07-02 |
| Model Number | HR-2615 |
| Catalog Number | HR-2615 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 463921 |
| Manufacturer | WESTERN/SCOTT FETZER CO. |
| Manufacturer Address | 875 BASSETT RD. WESTLAKE OH 441451142 US |
| Baseline Brand Name | HR-2615 |
| Baseline Generic Name | REGULATOR/FLOWMETER |
| Baseline Model No | HR-2615 |
| Baseline Catalog No | NA |
| Baseline ID | MHB9811-0073 |
| Baseline Device Family | HR-SERIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-02 |