MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for CONVERTORS 9575 manufactured by Cardinal Health 200, Llc.
[141322480]
Surgical gown had an intact dust cover, but a tear in the sterile blue wrap/paper label making the surgical gown non-sterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8495185 |
| MDR Report Key | 8495185 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-26 |
| Report Date | 2019-03-28 |
| Date Reported to FDA | 2019-03-28 |
| Date Reported to Mfgr | 2019-04-09 |
| Date Added to Maude | 2019-04-09 |
| 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 | CONVERTORS |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2019-04-09 |
| Model Number | 9575 |
| Catalog Number | 9575 |
| Lot Number | 18LBJ026 |
| 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 | 2019-04-09 |