MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-08-20 for DIAGNOSTIC DUETT PRO SEALING DEVICE 2210 NA manufactured by Vascular Solutions, Inc..
[301190]
Following deployment of the diagnostic duett pro, the patient experienced oozing at the puncture site. Attempts made by vsi to obtain patient treatment and status have been unsuccessful at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2003-00396 |
| MDR Report Key | 478821 |
| Report Source | 05,07 |
| Date Received | 2003-08-20 |
| Date of Report | 2003-08-20 |
| Date Mfgr Received | 2003-06-06 |
| Date Added to Maude | 2003-08-22 |
| 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 | AMANDA JOHNSON, ASSOCIATE |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564300 |
| 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 | DIAGNOSTIC DUETT PRO SEALING DEVICE |
| Generic Name | VASCULAR HEMOSTASIS DEVICE |
| Product Code | MHW |
| Date Received | 2003-08-20 |
| Model Number | 2210 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | * |
| 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 | 467633 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MINNEAPOLIS MN 55369 US |
| Baseline Brand Name | DIAGNOSTIC DUETT PRO |
| Baseline Generic Name | VASCULAR HEMOSTASIS DEVICE |
| Baseline Model No | 2210 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-20 |