MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-08-15 for 200902-ECG PLUS/SAT LT/EMC manufactured by 0700-c.r.bard Electrophysiology Product/glens Falls Manufacturing Operations.
[292664]
A pt had an ablation done with a labsystem and a carto system. After the procedure the pt had a burn on their right leg where the rl patch and lead wire were. Account stated that it was not a reaction to the patch. The burn necrosed the tissue with a 1/2 lesion and will be having plastic surgery on the spot. The pt is in stable condition and the stamp will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222791-2003-00010 |
| MDR Report Key | 477982 |
| Report Source | 06 |
| Date Received | 2003-08-15 |
| Date of Report | 2003-08-15 |
| Date Mfgr Received | 2003-07-18 |
| Date Added to Maude | 2003-08-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FAPPIANO, VP |
| Manufacturer Street | 55 TECHNOLOGY DRIVE |
| Manufacturer City | LOWELL MA 01851 |
| Manufacturer Country | US |
| Manufacturer Postal | 01851 |
| Manufacturer Phone | 9783232230 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 200902-ECG PLUS/SAT LT/EMC |
| Generic Name | 126010065-LABSYSTEMS |
| Product Code | DRQ |
| Date Received | 2003-08-15 |
| Model Number | NA |
| Catalog Number | 200902 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 466790 |
| Manufacturer | 0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT/GLENS FALLS MANUFACTURING OPERATIONS |
| Manufacturer Address | 289 BAY ROAD QUEENSBURY NY 12804 US |
| Baseline Brand Name | 200902-ECG PLUS/SAT LT/EMC |
| Baseline Generic Name | ECG PRESSURE PLUS MODULE |
| Baseline Catalog No | 200902 |
| Baseline Device Family | 126010065-LABSYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K913875 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-15 |