INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR 98434 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-01-15 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR 98434 N/A manufactured by Avanos Medical Inc..

MAUDE Entry Details

• Report Number: 9611594-2020-00008
• MDR Report Key: 9594439
• Report Source: DISTRIBUTOR,FOREIGN,OTHER
• Date Received: 2020-01-15
• Date of Report: 2020-01-15
• Date of Event: 2019-12-19
• Date Mfgr Received: 2019-12-30
• Device Manufacturer Date: 2018-06-27
• Date Added to Maude: 2020-01-15
• 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: 3
• Event Location: 3
• Manufacturer Contact: MS. LISA CLARK
• Manufacturer Street: 5405 WINDWARD PARKWAY
• Manufacturer City: ALPHARETTA GA 30004
• Manufacturer Country: US
• Manufacturer Postal: 30004
• Manufacturer Phone: 4704485444
• Manufacturer G1: AVENT SA DE R.L. DE C.V. (AVENT 1)
• Manufacturer Street: CIRCUITO INDUSTIAL NO.40 COLONIA OBRERA
• Manufacturer City: NOGALES, CP 84048
• Manufacturer Country: MX
• Manufacturer Postal Code: 84048
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 24FR DILATOR
• Generic Name: DH EF PERC PLACEMENT PRODUCTS
• Product Code: KGC
• Date Received: 2020-01-15
• Model Number: 98434
• Catalog Number: N/A
• Lot Number: AA8176R04
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AVANOS MEDICAL INC.
• Manufacturer Address: 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-15