TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-20 for TEST manufactured by Test.

MAUDE Entry Details

• Report Number: MW5001811
• MDR Report Key: 838997
• Date Received: 2007-04-20
• Date Added to Maude: 2007-04-20
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TEST
• Generic Name: TEST
• Product Code: LGE
• Date Received: 2007-04-20
• Returned To Mfg: 2007-04-14
• Model Number: TEST
• Catalog Number: TEST
• Lot Number: TEST
• ID Number: TEST
• Device Expiration Date: 2007-04-13
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 826299
• Manufacturer: TEST
• Manufacturer Address: TEST TEST TEST AK 234234234 US 234234

Device Sequence Number: 2

• Brand Name: TEST
• Generic Name: TEST
• Product Code: LGE
• Date Received: 2007-04-20
• Returned To Mfg: 2007-04-13
• Model Number: TEST
• Catalog Number: STE
• Lot Number: TEST
• ID Number: TEST
• Device Expiration Date: 2007-04-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Device Sequence No: 2
• Device Event Key: 826300
• Manufacturer: FINAL TESTING
• Manufacturer Address: TEST TEST TEST AK 234342342 US 2222

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-04-20