MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-30 for IMPRA CARBOFLO manufactured by Bard.
[775094]
Product was bard impra carboflo polytetrafluoroethylene prosthetic graft placed in the left upper arm position. Patient developed a large seroma of the axilla. On exploration of the left upper arm, the graft was seen to have excessively large amount serum "weeping" -ultrafiltrating- through the wall adjacent to the arterial anastamosis. Dates of use: 2007. Diagnosis or reason for use: dialysis access. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004578 |
| MDR Report Key | 958525 |
| Date Received | 2007-11-30 |
| Date of Report | 2007-11-30 |
| Date of Event | 2007-11-28 |
| Date Added to Maude | 2007-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRA CARBOFLO |
| Generic Name | DIALYSIS GRAFT |
| Product Code | FIQ |
| Date Received | 2007-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 931278 |
| Manufacturer | BARD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2007-11-30 |