DORNIER COMPACT DELTA II K1026730

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-15 for DORNIER COMPACT DELTA II K1026730 manufactured by Dornier Medtech Systems Gmbh.

MAUDE Entry Details

• Report Number: 1037955-2019-00028
• MDR Report Key: 8790722
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-07-15
• Date of Report: 2019-06-26
• Date of Event: 2019-06-05
• Date Facility Aware: 2019-06-26
• Report Date: 2019-07-15
• Date Reported to Mfgr: 2019-07-15
• Date Mfgr Received: 2019-06-26
• Device Manufacturer Date: 2011-08-31
• Date Added to Maude: 2019-07-15
• Event Key: 0
• Report Source Code: Distributor 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: MR. CHRIS FELABOM
• Manufacturer Street: 1155 ROBERTS BLVD. SUITE 100
• Manufacturer City: KENNESAW GA 30144
• Manufacturer Country: US
• Manufacturer Postal: 30144
• Manufacturer Phone: 7705146106
• Manufacturer G1: DORNIER MEDTECH SYSTEMS GMBH
• Manufacturer Street: ARGELSRIEDER FELD 7
• Manufacturer City: WESSLING, D-82234
• Manufacturer Country: GM
• Manufacturer Postal Code: D-82234
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DORNIER COMPACT DELTA II
• Generic Name: LITHOTRIPTER
• Product Code: LNS
• Date Received: 2019-07-15
• Model Number: COMPACT DELTA II
• Catalog Number: K1026730
• Device Availability: Y
• Device Age: 8 YR
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DORNIER MEDTECH SYSTEMS GMBH
• Manufacturer Address: ARGELSRIEDER FELD 7 WESSLING, D-82234 GM D-82234

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-15