MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-04-12 for BYRD DILATOR SHEATH SET, TEFLON LR-TEFBES002 manufactured by Cook Vascular Inc.
[19234609]
Tamponade/hemopericardium. Per comments on database report form: "developed tamponade at end of uneventful procedure. Trans-esophageal echo confirmed diagnosis. 500 ml drained with pericardial drainage. ".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2522007-2000-00008 |
| MDR Report Key | 273728 |
| Report Source | 05 |
| Date Received | 2000-04-12 |
| Date of Report | 2000-03-28 |
| Date of Event | 2000-02-23 |
| Date Mfgr Received | 2000-03-28 |
| Date Added to Maude | 2000-04-18 |
| 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 | RICHARD SHIRLEY |
| Manufacturer Street | PO BOX 529 ROUTE 66 RIVER RD |
| Manufacturer City | LEECHBURG PA 15656 |
| Manufacturer Country | US |
| Manufacturer Postal | 15656 |
| Manufacturer Phone | 7248458621 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BYRD DILATOR SHEATH SET, TEFLON |
| Generic Name | CATHETER RETRIEVAL DEVICE |
| Product Code | GCC |
| Date Received | 2000-04-12 |
| Model Number | LR-TEFBES002 |
| Catalog Number | LR-TEFBES002 |
| Lot Number | UNK |
| 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 | 264971 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | RTE 66 RIVER RD PO BOX 529 LEECHBURG PA 15656 US |
| Baseline Brand Name | BYRD DILATOR SHEATH SET TEFLON |
| Baseline Generic Name | CATHETER RETRIEVAL DEVICE |
| Baseline Model No | LR-TEFBES002 |
| Baseline Catalog No | LR-TEFBES002 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-12 |