MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for 127566A manufactured by Novo Health Services.
[100678017]
Patient Sequence No: 1, Text Type: N, H10
[100678018]
As i was opening for a total knee, the drape for the double basin had a hole in it. I had already put it on the table when we found it, but it wasn't touching anything. We removed it before continuing. We opened an ioban to cover the contaminated area and made sure nothing was put in that area. Once i scrubbed in, i covered the contaminated area with the ioban and changed my gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7288581 |
| MDR Report Key | 7288581 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-12 |
| Date of Event | 2018-02-01 |
| Report Date | 2018-02-12 |
| Date Reported to FDA | 2018-02-12 |
| Date Reported to Mfgr | 2018-02-12 |
| Date Added to Maude | 2018-02-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Generic Name | DRAPE, BASIN PACK |
| Product Code | KGT |
| Date Received | 2018-02-22 |
| Model Number | 127566A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO HEALTH SERVICES |
| Manufacturer Address | 2595 CUSTER RD STE B SALT LAKE CITY UT 84104 US 84104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |