NUPREP GEL 4OZ 10-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-05-03 for NUPREP GEL 4OZ 10-30 manufactured by D.o. Weaver Co..

Event Text Entries

[2083740] Female pt was being treated with biofeedback/eeg by clinician. Site or sites on scalp developed infection, possibly staph infection.
Patient Sequence No: 1, Text Type: D, B5

[9109882] We reviewed the device history file. No other injury complaints from this lot of product.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1718791-2011-00003
• MDR Report Key: 2086537
• Report Source: 05,08
• Date Received: 2011-05-03
• Date of Report: 2011-05-03
• Date of Event: 2011-04-05
• Date Mfgr Received: 2011-04-05
• Device Manufacturer Date: 2010-06-15
• Date Added to Maude: 2011-05-13
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DAVID WEAVER
• Manufacturer Street: 565 NUCLA WAY
• Manufacturer City: AURORA CO 80011
• Manufacturer Country: US
• Manufacturer Postal: 80011
• Manufacturer Phone: 3033661804
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NUPREP GEL 4OZ
• Generic Name: NUPREP GEL 4OZ
• Product Code: GYB
• Date Received: 2011-05-03
• Model Number: 10-30
• Catalog Number: 10-30
• Lot Number: 665
• ID Number: NA
• Device Expiration Date: 2013-06-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: D.O. WEAVER CO.
• Manufacturer Address: AURORA CO US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-05-03