KIT,OPEN HEART CON 933 Adverse Event — Malfunction (MDR 1423537-2020-00452)
KIT,OPEN HEART CON 933 Adverse Event — Malfunction (MDR 1423537-2020-00452) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: KIT,OPEN HEART CON 933; Generic name: CARDIOVASCULAR PROCEDURE KIT; Manufacturer: MEX03 MEXICO-JUAREZ PRESOURCE.
| Device | KIT,OPEN HEART CON 933 |
|---|---|
| Generic name | CARDIOVASCULAR PROCEDURE KIT |
| Manufacturer | MEX03 MEXICO-JUAREZ PRESOURCE |
| Report number | 1423537-2020-00452 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | FROM THE DEVICE HISTORY RECORD, LOT#20191211-23-SH WAS MANUFACTURED ON 12/12/2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.165G / 10 PIECES. THE ACTUAL COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, BUT A PHOTO WAS PROVIDED. THE PHOTO APPEAR TO SHOW BLUE LINT ON THE GLOVES. ACCORDING TO SUPPLIER, OR TOWEL |
| Source | openFDA MAUDE (device adverse events) |
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