MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1996-09-23 for COAXESS UTERINE CATHETER SLU-003 NA manufactured by Conceptus , Inc..
[29788]
Catheter perforated proximal section of the fallopian tube during a falloposcopy procedure. This is an anticipated adverse event as indicated in the product labeling. The adverse event is marked "other" because it is unknown as to whether the adverse event results in permanent impairment of body function or permanent damage to body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-1996-00001 |
| MDR Report Key | 44605 |
| Report Source | 01,05,07 |
| Date Received | 1996-09-23 |
| Date of Report | 1996-09-23 |
| Date of Event | 1996-08-23 |
| Date Mfgr Received | 1996-08-23 |
| Date Added to Maude | 1996-10-28 |
| 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 | COAXESS UTERINE CATHETER |
| Generic Name | INTRAUTERINE CATHETER |
| Product Code | HGS |
| Date Received | 1996-09-23 |
| Model Number | SLU-003 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45520 |
| Manufacturer | CONCEPTUS , INC. |
| Manufacturer Address | 1021 HOWARD AVE SAN CARLOS CA 94070 US |
| Baseline Brand Name | COAXESS UTERINE CATHETER |
| Baseline Generic Name | INTRAUTERINE CATHETERS |
| Baseline Model No | SLU-003 |
| Baseline Catalog No | SLU-003 |
| Baseline ID | NA |
| Baseline Device Family | UTERINE CATHETERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K962587 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-23 |