MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2002-12-06 for FEMORAL CATHETER N/A KF-15T manufactured by Medcomp.
[17177510]
"5 min after tubing connection, the pt became red, was hot and had breathing difficulty. Injection of solumedrol 1. 5ml. Then injection of adrenalin. Respiratory failure, with no tension drop nor cardiac arrest. The pt was intubated and ventilated. Removal of the respirator within 2h, the pt woke up 4hr after the incident without remembering anything. The pt is now in 'good shape' for an elderly and sick lady. This pt had an allergic disposition, as said by a family member, for instance, they were allergic to paracetamol".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2002-00234 |
| MDR Report Key | 431659 |
| Report Source | 01,08 |
| Date Received | 2002-12-06 |
| Date of Report | 2002-11-15 |
| Date of Event | 2002-11-13 |
| Date Mfgr Received | 2002-11-15 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2002-12-11 |
| 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 DR |
| 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 | 2002-12-06 |
| Model Number | N/A |
| Catalog Number | KF-15T |
| Lot Number | M223890 |
| ID Number | NA |
| Device Expiration Date | 2007-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 420644 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | FEMORAL CATHETER |
| Baseline Generic Name | HEMODIALYSIS CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | KF-15T |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-12-06 |