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.
[136730775]
A non-reinforced surgical gown came from the manufacturer wrapped improperly rendering it non-sterile. This was noticed before it was opened to the surgical field; however, had it been opened it would have contaminated the entire field. The gown was set aside in the wrapping and the information will be circulated though the unit to provide education and prevent contamination of any cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8357214 |
| MDR Report Key | 8357214 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-09 |
| Report Date | 2019-02-15 |
| Date Reported to FDA | 2019-02-15 |
| 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 | 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 | 2019-02-21 |
| Catalog Number | 9575 |
| Lot Number | 18KBJ027 |
| Device Availability | N |
| 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 |