MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-09 for SCRUB CARE DRY SURGICAL SCRUB 4454A * manufactured by Cardinal Health.
[1712163]
Large lint was observed upon opening a sterile scrub brush.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1992903 |
| MDR Report Key | 1992903 |
| Date Received | 2011-02-09 |
| Date of Report | 2011-02-09 |
| Date of Event | 2011-02-07 |
| Report Date | 2011-02-09 |
| Date Reported to FDA | 2011-02-09 |
| Date Added to Maude | 2011-02-16 |
| 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 | 0 |
| 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 | SCRUB CARE DRY SURGICAL SCRUB |
| Generic Name | DRY SURGICAL SCRUB |
| Product Code | GEC |
| Date Received | 2011-02-09 |
| Model Number | 4454A |
| Catalog Number | * |
| Lot Number | Y010K0597 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-09 |