EARIGATOR EAR-GRB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-04 for EARIGATOR EAR-GRB manufactured by Surya Technologies International.

Event Text Entries

[214619] Received a earigator (ear irrigator) from surya technologies international, model: ear-grb, 120 volts and for $3,495. 00. Outpatient clinic requested this device. The operator manual spec states that the water pressure range is 10 to 12 psi. When tested at the hand piece nozzle tip, it is a little over 23 psi under a no flow condition and very little pressure under a flow condition. The co rep told the rptr that the mfr said that the pressure would be "all right". Surya technologies international faxed rptr a copy of a letter from the fda, office of device evaluation, re: k992840, trade name: earigator ear cleansing instrument, dated 8/31/99. This letter states that the office reviewed surya premarket notification submission and have found this device to be exempt form the premarket notification requirements of the federal food, drug and cosmetic act. This letter states that "you (surya) may immediately begin marketing this device as described in your (surya) premarket notification". Rptr is requesting technical advice or the fda protocol for verifing the safety and performance of this device before use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002920
• MDR Report Key: 311060
• Date Received: 2001-01-04
• Date of Report: 2001-01-04
• Date Added to Maude: 2001-01-09
• 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
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EARIGATOR
• Generic Name: EAR IRRIGATOR 120 VOLTS
• Product Code: JYH
• Date Received: 2001-01-04
• Model Number: EAR-GRB
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 300891
• Manufacturer: SURYA TECHNOLOGIES INTERNATIONAL
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-01-04