MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for CARDINAL C-SECTION PACK manufactured by Cardinal Health 200, Llc.
[180793348]
Component (bard-parker size 10 blade, lot # 0204656) of cardinal c-section pack would not cut through tissue and disposable scalpel was needed to proceed with case. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093163 |
| MDR Report Key | 9739414 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-14 |
| Date Added to Maude | 2020-02-21 |
| 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 | 3 |
| Brand Name | CARDINAL C-SECTION PACK |
| Generic Name | CESAREAN SECTION TRAY |
| Product Code | OHM |
| Date Received | 2020-02-20 |
| Lot Number | 372640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |