KENDALL 7325 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-16 for KENDALL 7325 * manufactured by Kendall Co..

Event Text Entries

[345203] Upon removal of pas stockings pt was noted to have bilateral bruising of the lower legs where the stockings had been. This is the third incident since 9/2004.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034660
• MDR Report Key: 575039
• Date Received: 2005-02-16
• Date of Report: 2005-02-10
• Date of Event: 2005-01-26
• Date Added to Maude: 2005-02-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KENDALL
• Generic Name: PAS STOCKINGS
• Product Code: DWL
• Date Received: 2005-02-16
• Model Number: 7325
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 564887
• Manufacturer: KENDALL CO.
• Manufacturer Address: 15 HAMPSHIRE ST. MANSFIELD MA 02048 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-02-16