MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for PRESOURCE PACK GEN LAP CHOLE DRMC SLC56LCDA2 manufactured by Cardinal Health 200, Llc.
[125296705]
The mayo stand cover that came in the pack had some unknown matter on it that was sticky and debris that kept it from opening all the way. The charge nurse advised myself and the scrub technician to tear down the whole back table and open new equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8013543 |
| MDR Report Key | 8013543 |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-19 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-10-29 |
| Date Added to Maude | 2018-10-29 |
| 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 | 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 PACK GEN LAP CHOLE DRMC |
| Generic Name | GENERAL, TRAY, SURGERY |
| Product Code | LRP |
| Date Received | 2018-10-29 |
| Model Number | SLC56LCDA2 |
| Catalog Number | SLC56LCDA2 |
| Lot Number | 966892 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-10-29 |