MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for CLEARIFY VISUALIZATION SYSTEM 21-345 (01)10884521213562 manufactured by Covidien.
[106970713]
When handing off supplies after draping for the procedure the clarify unit dripped brownish fluid onto the drape. The drapes were removed and new supplies opened. The supplies were sequestered for examination by quality department team. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076887 |
| MDR Report Key | 7472559 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-04-11 |
| Date Added to Maude | 2018-04-30 |
| 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 |
| 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 | CLEARIFY VISUALIZATION SYSTEM |
| Generic Name | CLARIFY |
| Product Code | OCT |
| Date Received | 2018-04-27 |
| Model Number | 21-345 |
| Catalog Number | (01)10884521213562 |
| Lot Number | P8A1149HX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |