BACK TABLE COVER, BACK TABLE COVER, 50" X 90" - HANDI-BIN 42223NS 104222300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-07-26 for BACK TABLE COVER, BACK TABLE COVER, 50" X 90" - HANDI-BIN 42223NS 104222300 manufactured by O&m Halyard, Inc..

MAUDE Entry Details

• Report Number: 3005997949-2019-00007
• MDR Report Key: 8834121
• Report Source: DISTRIBUTOR,USER FACILITY
• Date Received: 2019-07-26
• Date of Report: 2019-09-06
• Date Mfgr Received: 2019-09-06
• Date Added to Maude: 2019-07-26
• 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: SCOTT MCKENTLY
• Manufacturer Street: 5405 WINDWARD PARWAY
• Manufacturer City: ALPHARETTA GA 30004
• Manufacturer Country: US
• Manufacturer Postal: 30004
• Manufacturer Phone: 4704485926
• Manufacturer G1: AVENT SA DE R.L. DE C.V. (AVENT 3)
• Manufacturer Street: AV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO
• Manufacturer City: NOGALES, COL.EDUCATIVA 84093
• Manufacturer Country: MX
• Manufacturer Postal Code: 84093
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BACK TABLE COVER, BACK TABLE COVER, 50" X 90" - HANDI-BIN
• Generic Name: EQUIPMENT COVERS
• Product Code: PUI
• Date Received: 2019-07-26
• Model Number: 42223NS
• Catalog Number: 104222300
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: O&M HALYARD, INC.
• Manufacturer Address: 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-26