MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for CONVERTORS 9575 manufactured by Cardinal Health 200, Llc.
[136730305]
The dust cover was taken off of a sterile gown to open it onto the operative field and noticed that the blue wrap was not fully covering the gown, therefore making the gown contaminated. The gown with identifying paper work to the manager. This is not the first time this has happened. The gowns are coming from the manufacturer this way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8357205 |
| MDR Report Key | 8357205 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-19 |
| Report Date | 2019-02-19 |
| Date Reported to FDA | 2019-02-19 |
| Date Reported to Mfgr | 2019-02-21 |
| Date Added to Maude | 2019-02-21 |
| 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 | CONVERTORS |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2019-02-21 |
| Model Number | 9575 |
| Catalog Number | 9575 |
| Lot Number | 18KBJ027 |
| Device Availability | Y |
| 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 | 2019-02-21 |