MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for CARDINAL HEALTH SMA56LP20A manufactured by Cardinal Health 200, Llc.
[94210062]
Patient Sequence No: 1, Text Type: N, H10
[94210063]
Scrub tech opened pack for urology case, they found hair inside sterile pack. We broke down back table and wasted all items included in pack and opened new pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7098968 |
| MDR Report Key | 7098968 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-12-03 |
| Report Date | 2017-12-05 |
| Date Reported to FDA | 2017-12-05 |
| Date Reported to Mfgr | 2017-12-05 |
| Date Added to Maude | 2017-12-08 |
| 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 |
| 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 | HYSTERECTOMY KIT |
| Product Code | OJF |
| Date Received | 2017-12-08 |
| Model Number | SMA56LP20A |
| Catalog Number | SMA56LP20A |
| Lot Number | 722215 |
| ID Number | 221852 |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-08 |