MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-04-18 for USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD GDAC manufactured by Circon Acmi.
| Report Number | 1519132-2000-00019 |
| MDR Report Key | 275027 |
| Report Source | 06 |
| Date Received | 2000-04-18 |
| Date of Report | 2000-04-18 |
| Date of Event | 2000-03-10 |
| Date Mfgr Received | 2000-03-23 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 2000-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY PICKARD |
| Manufacturer Street | 300 STILLWATER AVENUE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033288721 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD |
| Generic Name | ACTIVE CORD |
| Product Code | FFZ |
| Date Received | 2000-04-18 |
| Model Number | GDAC |
| Catalog Number | GDAC |
| Lot Number | CC (3/99) |
| ID Number | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 266200 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 N PLEASANT ST NORWALK OH 448570409 US |
| Baseline Brand Name | USA ELITE SYSTEM/USA SERIES DISPOSABLE ACTIVE CORD |
| Baseline Generic Name | 500 |
| Baseline Model No | GDAC |
| Baseline Catalog No | GDAC |
| Baseline Device Family | R2500 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-18 |