DISPOSABLE MIXING BOWL AND SPATULA 00504901100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2011-11-23 for DISPOSABLE MIXING BOWL AND SPATULA 00504901100 manufactured by Zimmer Inc.

Event Text Entries

[2371485] It was reported that a foreign substance was found inside the disposable mixing bowl when the nurse opened the sterile pouch.
Patient Sequence No: 1, Text Type: D, B5

[9678089] This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1822565-2011-02602
• MDR Report Key: 2395150
• Report Source: 01,05,08
• Date Received: 2011-11-23
• Date of Report: 2011-10-24
• Date of Event: 2011-10-19
• Date Mfgr Received: 2011-10-24
• Device Manufacturer Date: 2011-03-01
• Date Added to Maude: 2012-01-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Event Location: 0
• Manufacturer Contact: KEVIN ESCAPULE
• Manufacturer Street: P.O. BOX 708
• Manufacturer City: WARSAW IN 465810708
• Manufacturer Country: US
• Manufacturer Postal: 465810708
• Manufacturer Phone: 8006136131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DISPOSABLE MIXING BOWL AND SPATULA
• Product Code: GAF
• Date Received: 2011-11-23
• Returned To Mfg: 2011-11-10
• Catalog Number: 00504901100
• Lot Number: 61714950
• Device Expiration Date: 2016-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER INC
• Manufacturer Address: P.O. BOX 708 WARSAW IN 46581070 US 46581 0708

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-11-23