MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2001-11-09 for FEMORAL CATHETER MCF55PS* manufactured by Medcomp Medical Components, Inc..
[18558223]
It was reported that the catheter broke internally at home. The catheter had been implanted for two weeks. It was surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2001-00191 |
| MDR Report Key | 360839 |
| Report Source | 01,08 |
| Date Received | 2001-11-09 |
| Date of Report | 2001-09-21 |
| Date of Event | 2000-12-01 |
| Date Mfgr Received | 2001-09-21 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2001-11-26 |
| 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 |
| Manufacturer Contact | SUSAN SMITH, RN |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 2001-11-09 |
| Returned To Mfg | 2001-10-01 |
| Model Number | NA |
| Catalog Number | MCF55PS* |
| Lot Number | M915250 |
| ID Number | NA |
| Device Expiration Date | 2004-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 349997 |
| Manufacturer | MEDCOMP MEDICAL COMPONENTS, INC. |
| Manufacturer Address | 1499 DELP DR HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | FEMORAL CATHETER |
| Baseline Generic Name | .035 X 70CM J FLEX GUIDEWIRE |
| Baseline Catalog No | MCF55PS* |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 27 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-09 |