DAVOL INC. 0031050 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-04 for DAVOL INC. 0031050 * manufactured by Davol, Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[20766176] Frazier suction tip, 3fr and 5fr disconnected while surgeon was suctioning pt's ear.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015849
• MDR Report Key: 213142
• Date Received: 1999-03-04
• Date Added to Maude: 1999-03-10
• 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: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: DAVOL INC.
• Generic Name: FRAZIER SURGICAL SUCTION INSTRUMENT
• Product Code: JZF
• Date Received: 1999-03-04
• Model Number: 0031050
• Catalog Number: *
• Lot Number: *
• ID Number: "ASSEM IN MEXICO"
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 206802
• Manufacturer: DAVOL, INC., SUB. C.R. BARD, INC.
• Manufacturer Address: 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US

Device Sequence Number: 2

• Brand Name: DAVOL INC.
• Generic Name: FRAZIER SURGICAL SUCTION INSTRUMENT
• Product Code: JZF
• Date Received: 1999-03-04
• Model Number: 0031030
• Catalog Number: *
• Lot Number: *
• ID Number: "ASSEM IN MEXICO"
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 206803
• Manufacturer: DAVOL, INC., SUB. C.R. BARD, INC.
• Manufacturer Address: 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-03-04