11.25CM ATTACHMENT, BLACK MAX B-BLUE-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-04 for 11.25CM ATTACHMENT, BLACK MAX B-BLUE-S manufactured by Depuy Synthes Products Llc.

MAUDE Entry Details

• Report Number: 1045834-2019-54436
• MDR Report Key: 8960759
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-04
• Date of Report: 2019-07-25
• Date of Event: 2019-01-01
• Date Mfgr Received: 2019-08-23
• Device Manufacturer Date: 2009-08-26
• Date Added to Maude: 2019-09-04
• 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. KARA DITTY-BOVARD
• Manufacturer Street: 4500 RIVERSIDE DRIVE
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal: 33410
• Manufacturer Phone: 6103142063
• Manufacturer G1: DEPUY SYNTHES PRODUCTS LLC
• Manufacturer Street: 4500 RIVERSIDE DRIVE
• Manufacturer City: PALM BEACH GARDENS FL 33410
• Manufacturer Country: US
• Manufacturer Postal Code: 33410
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 11.25CM ATTACHMENT, BLACK MAX
• Generic Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
• Product Code: GFF
• Date Received: 2019-09-04
• Returned To Mfg: 2017-03-22
• Catalog Number: B-BLUE-S
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY SYNTHES PRODUCTS LLC
• Manufacturer Address: 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-04