MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06 report with the FDA on 1997-01-17 for DEVICE #1 4870-26 manufactured by Smiths Industries Medical Systems.
[15449078]
The pt underwent the cvs procedure at 11 weeks gestation. Two transcervical passes were made. Intrauterine fetal demise was found at 15 weeks gestation and was estimated based on fetal size, to have occurred between 10-12 weeks gestation. A d&c was performed. The pathology report states that the fetus was masserated, partially dehydrated and the umbilical cord was wrapped twice around the neck. A d&c was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-1997-00006 |
| MDR Report Key | 62758 |
| Report Source | 02,05,06 |
| Date Received | 1997-01-17 |
| Date of Report | 1996-12-18 |
| Date of Event | 1995-12-04 |
| Date Mfgr Received | 1996-12-18 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 1997-01-21 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVICE #1 |
| Generic Name | CATHETER, SAMPLING, CHORNIC VILLUS |
| Product Code | LLX |
| Date Received | 1997-01-17 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | 508582 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 63007 |
| Manufacturer | SMITHS INDUSTRIES MEDICAL SYSTEMS |
| Manufacturer Address | 15 KIT ST KEENE NH 03431 US |
| Baseline Brand Name | TROPHOCAN CVS CATHETER |
| Baseline Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Baseline Model No | NA |
| Baseline Catalog No | 4870-26 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-01-17 |