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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-23 for * manufactured by *.

Event Text Entries

[351861] Microwave ovens are supplied by the manufacturers of some devices, such as towelettes to warm them for patient comfort. The problem is that the temperature of the device cannot be determined when it is removed from the microwave. Staff may repeat warming if the device does not feel warm to the touch. A more insidious problem is also developed by the use of microwaves in this manner. The staff come to believe that it is reasonable to use a microwave to heat various things, such as bath towels, capd continuous abdominal peritoneal dialysis fluids etc. , in microwave ovens. It becomes an issue of "normalization of deviance" to borrow a phrase.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 549788
• MDR Report Key: 549788
• Date Received: 2003-04-23
• Date of Report: 2003-04-23
• Report Date: 2003-04-23
• Date Reported to FDA: 2003-04-23
• Date Added to Maude: 2004-10-21
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: *
• Generic Name: OTHER
• Product Code: LHF
• Date Received: 2003-04-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 539299
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-04-23