MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for ANGIO TRAY DYNJ49372A manufactured by Medline Industries.
[101772402]
In the cath lab, device placed on top of a towel prior to re entry device wiped down and large amount of lint on device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075666 |
| MDR Report Key | 7316494 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-15 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ANGIO TRAY |
| Generic Name | ANGIO TRAY |
| Product Code | OEQ |
| Date Received | 2018-03-05 |
| Model Number | DYNJ49372A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-05 |