DRYZ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-07 for DRYZ * manufactured by Parkell.

Event Text Entries

[18727208] Patient experienced a burning sensation directly after product was applied. Diagnosis or reason for use: temporary retraction and hemostasis of the gingival margin. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5034893
• MDR Report Key: 3675351
• Date Received: 2014-03-07
• Date of Report: 2014-03-06
• Date of Event: 2014-03-06
• Date Added to Maude: 2014-03-13
• 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: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRYZ
• Generic Name: DRYZ
• Product Code: MVL
• Date Received: 2014-03-07
• Model Number: *
• Catalog Number: *
• Lot Number: 13309
• ID Number: *
• Device Expiration Date: 2014-12-01
• Operator: OTHER
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PARKELL
• Manufacturer Address: * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-07