MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-08-22 for 200915-STAMP PLATFORM/115V manufactured by 0700-c.r.bard Electrophysiology Product.
[300519]
It has been reported that the pt received a burn on the right leg during the procedure from this device. The pt's condition is unk and the sample is being returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222791-2003-00012 |
| MDR Report Key | 479329 |
| Report Source | 07 |
| Date Received | 2003-08-22 |
| Date of Report | 2003-08-21 |
| Date of Event | 2003-08-12 |
| Date Mfgr Received | 2003-08-18 |
| Date Added to Maude | 2003-08-25 |
| 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 | 0700-C.R. BARD ELECTROPHYSIOLOGY PRODUCT |
| Manufacturer Street | 55 TECHNOLOGY DRIVE |
| Manufacturer City | LOWELL MA 01851 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01851 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 200915-STAMP PLATFORM/115V |
| Generic Name | 126010065-LABSYSTEMS |
| Product Code | DRQ |
| Date Received | 2003-08-22 |
| Model Number | NA |
| Catalog Number | 200915 |
| 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 | 468170 |
| Manufacturer | 0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT |
| Manufacturer Address | 289 BAY ROAD GLENS FALLS MFG. OPERATIONS QUEENSBURY NY 12804 US |
| Baseline Brand Name | 200915-STAMP PLATFORM/115V |
| Baseline Catalog No | 200915 |
| 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 | 2003-08-22 |