MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-14 for SCRUB CARE DRY SURGICAL SCRUB BRUSH-SPONGE/NAIL CLEANER 4454A * manufactured by Carefusion.
[2546391]
The nurse opened a sterile scrub to be used on patient and discovered what appeared to be a small worm embedded in the brush.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2494126 |
MDR Report Key | 2494126 |
Date Received | 2012-03-14 |
Date of Report | 2012-03-14 |
Date of Event | 2012-03-02 |
Report Date | 2012-03-14 |
Date Reported to FDA | 2012-03-14 |
Date Added to Maude | 2012-03-16 |
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 BRUSH-SPONGE/NAIL CLEANER |
Generic Name | OR SCRUB |
Product Code | GEC |
Date Received | 2012-03-14 |
Model Number | 4454A |
Catalog Number | * |
Lot Number | 0000388227 |
ID Number | * |
Operator | NURSE |
Device Availability | Y |
Device Age | 1 DY |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CAREFUSION |
Manufacturer Address | 3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2012-03-14 |