DISTRACTION 51-556-20-09

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-21 for DISTRACTION 51-556-20-09 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.

MAUDE Entry Details

• Report Number: 9610905-2019-00192
• MDR Report Key: 9214774
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-10-21
• Date of Report: 2019-10-11
• Date of Event: 2019-10-11
• Date Facility Aware: 2019-10-11
• Report Date: 2019-10-11
• Date Reported to Mfgr: 2019-10-11
• Date Mfgr Received: 2019-10-11
• Date Added to Maude: 2019-10-21
• 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. JENNIFER DAMATO
• Manufacturer Street: P.O. BOX 16369
• Manufacturer City: JACKSONVILLE FL 32245
• Manufacturer Country: US
• Manufacturer Postal: 32245
• Manufacturer Phone: 9046417746
• Manufacturer G1: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
• Manufacturer Street: KOLBINGER STRASSE 10
• Manufacturer City: MUEHLHEIM/DONAU, 78570
• Manufacturer Country: GM
• Manufacturer Postal Code: 78570
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DISTRACTION
• Generic Name: DISTRACTION
• Product Code: MQN
• Date Received: 2019-10-21
• Model Number: 51-556-20-09
• Lot Number: 33263985
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
• Manufacturer Address: KOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-21