MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for PRESOURCE SMA56LP20A manufactured by Cardinal Health 200, Llc.
[134861977]
It was brought to my attention today, that one of the presource packs was stocked with ray tecs that do not work with our counting system. This is the first one that i have been made aware of and not sure how often this has happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8300885 |
| MDR Report Key | 8300885 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-23 |
| Date of Event | 2019-01-23 |
| Report Date | 2019-01-23 |
| Date Reported to FDA | 2019-01-23 |
| Date Reported to Mfgr | 2019-02-04 |
| Date Added to Maude | 2019-02-04 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PRESOURCE |
| Generic Name | HYSTERECTOMY KIT |
| Product Code | OJF |
| Date Received | 2019-02-04 |
| Model Number | SMA56LP20A |
| Catalog Number | SMA56LP20A |
| Lot Number | 127147 |
| Device Availability | Y |
| Device Age | 2 MO |
| 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 | 2019-02-04 |