DRAPE TAPES 3524CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2003-06-17 for DRAPE TAPES 3524CE manufactured by Cardinal Health.

Event Text Entries

[273785] During the withdrawal, the adhesives bands snatched away the skin of the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423507-2003-00082
• MDR Report Key: 466186
• Report Source: 01,05,07
• Date Received: 2003-06-17
• Date of Report: 2003-06-17
• Date of Event: 2003-05-21
• Date Mfgr Received: 2003-05-22
• Device Manufacturer Date: 2002-05-01
• Date Added to Maude: 2003-06-19
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: PATRICIA SHARPE-GREGG
• Manufacturer Street: 1430 WAUKEGAN RD
• Manufacturer City: MCGAW PARK IL 60085
• Manufacturer Country: US
• Manufacturer Postal: 60085
• Manufacturer Phone: 8475784148
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRAPE TAPES
• Generic Name: DRAPE TAPES
• Product Code: KGT
• Date Received: 2003-06-17
• Model Number: 3524CE
• Catalog Number: 3524CE
• Lot Number: 02EBJ001
• ID Number: *
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 455129
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US
• Baseline Brand Name: DRAPE TAPES
• Baseline Generic Name: DRAPE TAPES
• Baseline Model No: 3524CE
• Baseline Catalog No: 3524CE
• Baseline Device Family: SURGICAL ACCESSORY
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-06-17