MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-06-06 for IRT DELIVERY DEVICE WITH 10 SEED RIBBON 508010P manufactured by Cordis Corp. (miami).
[246385]
Source ribbon exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016427-2002-00109 |
| MDR Report Key | 398371 |
| Report Source | 07 |
| Date Received | 2002-06-06 |
| Date of Report | 2002-06-06 |
| Date of Event | 2002-05-09 |
| Date Facility Aware | 2002-05-10 |
| Report Date | 2002-06-06 |
| Date Reported to Mfgr | 2002-05-10 |
| Date Mfgr Received | 2002-05-10 |
| Date Added to Maude | 2002-06-11 |
| 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 | 3 |
| Manufacturer Contact | MARY TAYLOR, RN,HCRM,CLINICIAN |
| Manufacturer Street | 14201 NW 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 3058242812 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRT DELIVERY DEVICE WITH 10 SEED RIBBON |
| Generic Name | RADIATION CATHETERS |
| Product Code | LHN |
| Date Received | 2002-06-06 |
| Model Number | NA |
| Catalog Number | 508010P |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 387413 |
| Manufacturer | CORDIS CORP. (MIAMI) |
| Manufacturer Address | 14420 NW 60TH AVENUE MIAMI LAKES FL 33014 US |
| Baseline Brand Name | CHECKMATE |
| Baseline Generic Name | IRT DELIVERY DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 508010P |
| Baseline ID | NA |
| Baseline Device Family | RADIATION CATHETERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 35 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-06 |