MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-25 for MEDICHOICE UNIVERSAL ISOLATION YELLOW COVER GOWN * 0120130107 manufactured by Ozburn-hessey Logistics Llc.
[4752774]
Nicu staff found a bug and bug parts in an unopened package of isolation gowns. Package had not been opened and was removed from service and given to risk management. Packaging was intact. Appears bug/bug parts got into the gowns prior to arrival at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3972681 |
| MDR Report Key | 3972681 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-07-23 |
| Report Date | 2014-07-25 |
| Date Reported to FDA | 2014-07-25 |
| Date Reported to Mfgr | 2014-08-01 |
| Date Added to Maude | 2014-08-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE UNIVERSAL ISOLATION YELLOW COVER GOWN |
| Generic Name | NON-SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2014-07-25 |
| Model Number | * |
| Catalog Number | 0120130107 |
| Lot Number | 1312HO52B |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OZBURN-HESSEY LOGISTICS LLC |
| Manufacturer Address | 2255 E 220TH ST CARSON CA 90810 US 90810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-25 |