MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-12-18 for HEARTCARD manufactured by Instromedix.
| Report Number | 2032223-2002-00001 |
| MDR Report Key | 435081 |
| Report Source | 00 |
| Date Received | 2002-12-18 |
| Date of Event | 2002-11-01 |
| Date Mfgr Received | 2002-11-26 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 2003-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALDEN KAY |
| Manufacturer Street | 6779 MESA RIDGE ROAD SUITE 200 |
| Manufacturer City | SAN DIEGO CA 921212996 |
| Manufacturer Country | US |
| Manufacturer Postal | 921212996 |
| Manufacturer Phone | 8587772206 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTCARD |
| Generic Name | CARDIAC EVENT MONITOR |
| Product Code | DXH |
| Date Received | 2002-12-18 |
| Returned To Mfg | 2002-12-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 417452 |
| Manufacturer | INSTROMEDIX |
| Manufacturer Address | 6779 MESA RIDGE RD SUITE 200 SAN DIEGO CA 921212996 US |
| Baseline Brand Name | HEARTCARD |
| Baseline Generic Name | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE |
| Baseline Model No | 5258-10 |
| Baseline Catalog No | 5258-10 |
| Baseline Device Family | HEARTCARD |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K944362 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-18 |