CONFIDENCE KIT, NO NEEDLES 283913000

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 2020-02-05 for CONFIDENCE KIT, NO NEEDLES 283913000 manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

• Report Number: 1526439-2020-00496
• MDR Report Key: 9673242
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-05
• Date of Report: 2020-01-14
• Date of Event: 2020-01-14
• Date Mfgr Received: 2020-03-11
• Date Added to Maude: 2020-02-05
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARA DITTY-BOVARD
• Manufacturer Street: 1302 WRIGHT LANE EAST
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6107195000
• Manufacturer G1: BRIDGEWATER DISTRIBUTION
• Manufacturer Street: 50 SCOTLAND BOULEVARD
• Manufacturer City: BRIDGEWATER MA 02324
• Manufacturer Country: US
• Manufacturer Postal Code: 02324
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Generic Name: POLYMETHYLMETHACRYLATE BONE CEMENT
• Product Code: NDN
• Date Received: 2020-02-05
• Model Number: 283913000
• Catalog Number: 283913000
• Lot Number: 228525
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDOS INTERNATIONAL SàRL CH
• Manufacturer Address: CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-02-05