MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 1999-04-16 for TROPHOCAN CVS CATHETER 4876-20 manufactured by Sims Portex Inc..
[16264701]
The child of a mother who underwent the cvs procedure on 3/11/1991 was allegedly born with bilateral club feet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217052-1999-00012 |
| MDR Report Key | 219064 |
| Report Source | 00,04 |
| Date Received | 1999-04-16 |
| Date of Report | 1999-03-18 |
| Date of Event | 1991-03-11 |
| Date Mfgr Received | 1999-03-18 |
| Date Added to Maude | 1999-04-19 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 1999-04-16 |
| Model Number | NA |
| Catalog Number | 4876-20 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 212450 |
| 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 | 4876-20 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly | 1999-04-16 |