SCRUB CARE DRY SKIN PREP TRAY * 4461A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-02 for SCRUB CARE DRY SKIN PREP TRAY * 4461A manufactured by Cardinal Health.

Event Text Entries

[20733600] Gray/black flecks of debris were found in 2 separate packages of sterile dry skin preparation trays.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2682949
• MDR Report Key: 2682949
• Date Received: 2012-08-02
• Date of Report: 2012-08-02
• Date of Event: 2012-07-23
• Report Date: 2012-08-02
• Date Reported to FDA: 2012-08-02
• Date Added to Maude: 2012-08-06
• 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

Device Sequence Number: 1

• Brand Name: SCRUB CARE DRY SKIN PREP TRAY
• Generic Name: STERILE DRY SKIN PREP TRAYS
• Product Code: OJU
• Date Received: 2012-08-02
• Model Number: *
• Catalog Number: 4461A
• Lot Number: 0000434391
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD MPKB-2B WAUKEGAN IL 60085 US 60085

Device Sequence Number: 2

• Brand Name: SCRUB CARE DRY SKIN PREP TRAYS
• Generic Name: STERILE DRY SKIN PREP TRAYS
• Product Code: OJU
• Date Received: 2012-08-02
• Model Number: *
• Catalog Number: 4461A
• Lot Number: 0000436901
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD MPKB-2B WAUKEGAN IL 60085 US 60085

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-08-02