MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for BLUE IMPERVIOUS GOWN XL AT4441 manufactured by Cardinal Health.
[58478445]
Blue impervious xl gowns lot# 608231 250 ea, they all don't have lot numbers on them. Some have the lot on the side of box which is unreadable and if lot number is on side of box and there is a lot number on front of box, it doesn't match. Cat #at4441 they are made by cardinal health. Qty 75 in one box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6054817 |
| MDR Report Key | 6054817 |
| Date Received | 2016-10-20 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-20 |
| Date Facility Aware | 2016-10-19 |
| Report Date | 2016-10-20 |
| Date Reported to FDA | 2016-10-21 |
| Date Added to Maude | 2016-10-25 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLUE IMPERVIOUS GOWN XL |
| Generic Name | BLUE IMPERVIOUS GOWN W/THUMBROOKS |
| Product Code | OEA |
| Date Received | 2016-10-20 |
| Model Number | AT4441 |
| Lot Number | 608231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 600856787 US 600856787 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-20 |