MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,06 report with the FDA on 1996-11-14 for TROPHOCAN CVS CATHETER 4870-26 manufactured by Smiths Industries Medical Systems.
[24604]
The pt underwent the cvs procedure and one transcervical pass was made. The pt spontaneously aborted at 14 weeks gestation.
Patient Sequence No: 1, Text Type: D, B5
[7770468]
Co has received additional information from chief stenographer, at the user facility. Further investigation at the user facility found that the spontaneous pregnancy less reported was not due to the use of a co's product during the cvs procedure and was filed in error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-1996-00075 |
| MDR Report Key | 48660 |
| Report Source | 02,06 |
| Date Received | 1996-11-14 |
| Date of Report | 1996-10-15 |
| Date Mfgr Received | 1996-10-15 |
| Date Added to Maude | 1996-11-15 |
| 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 | TROPHOCAN CVS CATHETER |
| Generic Name | CATHETER, SAMPLING, CHORIONIC VILLUS |
| Product Code | LLX |
| Date Received | 1996-11-14 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 49425 |
| 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 | 1996-11-14 |