ZIMMON BILIARY STENT Adverse Event — Malfunction (MDR 3001845648-2020-00265)
ZIMMON BILIARY STENT Adverse Event — Malfunction (MDR 3001845648-2020-00265) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZIMMON BILIARY STENT; Generic name: FGE CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: COOK IRELAND LTD.
| Device | ZIMMON BILIARY STENT |
|---|---|
| Generic name | FGE CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | COOK IRELAND LTD |
| Report number | 3001845648-2020-00265 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | DEVICE EVALUATION: THE ZSO-7-5 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION Z |
| Source | openFDA MAUDE (device adverse events) |
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