MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-07-14 for COOK CHORIONIC VILLUS SAMPLING SET J-CVS-572700 manufactured by Cook Ob/gyn.
[17112047]
The pregnancy outcome form states that oromadibular/limb dystrophy had occurred, the child is missing the left hand. A follow up letter from the facility states that the pt had a cvs procedure using a cook cvs set on 08-12-98 and subsequently gave birth to a child with a terminal transverse limb anomaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825146-1999-00011 |
| MDR Report Key | 232576 |
| Report Source | 05,06 |
| Date Received | 1999-07-14 |
| Date of Report | 1999-07-14 |
| Date of Event | 1999-02-22 |
| Date Facility Aware | 1999-02-22 |
| Report Date | 1999-06-14 |
| Date Mfgr Received | 1999-06-01 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 1999-07-23 |
| 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 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic Name | SAMPLING DEVICE |
| Product Code | LLX |
| Date Received | 1999-07-14 |
| Model Number | NA |
| Catalog Number | J-CVS-572700 |
| Lot Number | 457029 |
| ID Number | SCO11998C |
| Device Expiration Date | 2003-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 225457 |
| Manufacturer | COOK OB/GYN |
| Manufacturer Address | 1100 WEST MORGAN ST. SPENCER IN 47460 US |
| Baseline Brand Name | COOK CHORIONIC VILLUS SAMPLING SET |
| Baseline Generic Name | SAMPLING DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | J-CVS-572700 |
| Baseline ID | NA |
| Baseline Device Family | UNCLASSIFIED |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 1999-07-14 |