MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for 9575 manufactured by Cardinal Health 200, Llc.
[143989199]
Blood got through md's gown and onto his scrubs and lead that he was wearing for a tha. The gowns that we currently use are supposed to be impermeable, but this is happening quite frequently with his tha.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8577228 |
| MDR Report Key | 8577228 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-15 |
| Report Date | 2019-04-24 |
| Date Reported to FDA | 2019-04-24 |
| Date Reported to Mfgr | 2019-05-03 |
| Date Added to Maude | 2019-05-03 |
| 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 |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2019-05-03 |
| Model Number | 9575 |
| Catalog Number | 9575 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |