MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-09-10 for GORE TEX UNK manufactured by W.l. Gore & Associates, Inc..
[153319]
43-year-old male admitted on 7/21/1996 with severe life-threatening hyperkalemia with congestive heart failure. Pt is on chronic hemodialysis and recently had a shunt replaced which was an upper arm loop configuration with recurrent reaccumulation of fluid in the axilla. Pt underwent an evacuation and debridement of left axillary fluid mass and replacement of shunt using 8 mm ring. Ptfe8 cm in length interposition graft on 7/31/1996. The graft was noticed to be weeping fluid through the interstices of the graft. The pt was discharged home on 8/3/1996.
Patient Sequence No: 1, Text Type: D, B5
[7763659]
Although the user facility reports that the info was provided to gore on 7/31/1996, we have no record of that occurrence. Pt's operative notes were attached to user report and are included with this follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025240-1996-00002 |
| MDR Report Key | 38288 |
| Report Source | 05 |
| Date Received | 1996-09-10 |
| Date of Report | 1996-09-09 |
| Date of Event | 1996-07-25 |
| Date Facility Aware | 1996-07-31 |
| Date Mfgr Received | 1996-08-12 |
| Date Added to Maude | 1996-09-18 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE TEX |
| Generic Name | EPTFE VASCULAR PROSTHESIS |
| Product Code | MCI |
| Date Received | 1996-09-10 |
| Returned To Mfg | 1996-08-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 39540 |
| Manufacturer | W.L. GORE & ASSOCIATES, INC. |
| Manufacturer Address | 3450 W KILTIE LANE FLAGSTAFF AZ 86002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-10 |