MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for CYSTO CUSTOM PACK manufactured by Cardinal Health.
[90659270]
Product pack says contains 10 raytec sponges and contained 11 raytec sponges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073021 |
| MDR Report Key | 6986682 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-11 |
| Date Added to Maude | 2017-10-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | CYSTO CUSTOM PACK |
| Generic Name | GENERAL SURGICAL TRAY |
| Product Code | LRP |
| Date Received | 2017-10-30 |
| Lot Number | 742590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |