MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 1998-01-30 for TROPHOCAN CVS CATHETER 4870-26 manufactured by Sims Portex, Inc..
[123020]
The patient experienced spotting, then bleeding and spontaneously aborted the fetus which had a possible ventral wall defect. The patient spiked a fever and required a d&c.
Patient Sequence No: 1, Text Type: D, B5
[7767022]
This follow-up report consists of additional information provide by the user facility. Any unk entry throughout this form indicates that this information is unknown because it was not recorded at the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-1998-00004 |
| MDR Report Key | 146369 |
| Report Source | 00,05 |
| Date Received | 1998-01-30 |
| Date of Event | 1997-09-03 |
| Date Mfgr Received | 1998-01-02 |
| Date Added to Maude | 1998-02-02 |
| 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 | 0 |
| 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 | 1998-01-30 |
| Model Number | NA |
| Catalog Number | 4870-26 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 142664 |
| Manufacturer | SIMS PORTEX, INC. |
| Manufacturer Address | 10 BOWMAN DR. 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 | 1998-01-30 |