DELTAFILL18 8MM X 35CM Adverse Event — Malfunction (MDR 3008114965-2020-00134)
DELTAFILL18 8MM X 35CM Adverse Event — Malfunction (MDR 3008114965-2020-00134) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DELTAFILL18 8MM X 35CM; Generic name: NEUROVASCULAR EMBOLIZATION DEVICE; Manufacturer: MEDOS INTERNATIONAL SARL.
| Device | DELTAFILL18 8MM X 35CM |
|---|---|
| Generic name | NEUROVASCULAR EMBOLIZATION DEVICE |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Report number | 3008114965-2020-00134 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | PRODUCT COMPLAINT #(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE ¿ (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NE |
| Source | openFDA MAUDE (device adverse events) |
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