BLAKE (R) DRAIN HBLS 15 FR Adverse Event — Malfunction (MDR 2210968-2020-03588)
BLAKE (R) DRAIN HBLS 15 FR Adverse Event — Malfunction (MDR 2210968-2020-03588) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BLAKE (R) DRAIN HBLS 15 FR; Generic name: CATHETER, IRRIGATION; Manufacturer: ETHICON INC..
| Device | BLAKE (R) DRAIN HBLS 15 FR |
|---|---|
| Generic name | CATHETER, IRRIGATION |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03588 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT COMPLAINT # PC-(B)(4). DATE SENT TO THE FDA: 5/26/2020. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION HAVE BEEN PERFORMED AND WAS RECEIVED. PLEASE CLARIFY, WHICH IS THE COMPLAINT PRODUCT AND WHAT WAS THE ISSUE WITH EACH: THE RESERVOIR AND 2 DAINS WERE RETURNED FROM THE HOSPITAL TO JAPAN UNDER THE CONDITION THAT THE DRAINS WERE CONNECTED TO THE RESERVOIR. THE ISSUE REPORTED BY THE CUSTOMER W |
| Source | openFDA MAUDE (device adverse events) |
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