MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for CARDINAL HEALTH SOP56TK80H manufactured by Cardinal Health 200, Llc.
[184467156]
While bringing the draped mayo stand into the sterile field, it was noticed that there were large holes in the drape along the side of the mayo stand. The surgeon was present and consulted and it was decided to remove the outer gloves of the scrub tech and cover the holes and any areas that she may have touched with sterile ioban. The inner wrapping of the pack which the mayo stand cover came in was saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9864863 |
| MDR Report Key | 9864863 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | CARDINAL HEALTH |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | OJH |
| Date Received | 2020-03-23 |
| Model Number | SOP56TK80H |
| Catalog Number | SOP56TK80H |
| Lot Number | 340859 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |