* 2219

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-07 for * 2219 manufactured by Addto, Inc..

Event Text Entries

[4241955] Catheter adapter broke.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3678805
• MDR Report Key: 3678805
• Date Received: 2014-03-07
• Date of Report: 2014-03-07
• Date of Event: 2013-11-16
• Report Date: 2014-03-07
• Date Reported to FDA: 2014-03-07
• Date Reported to Mfgr: 2014-03-14
• Date Added to Maude: 2014-03-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: ADAPTOR, URETERAL CATHETER
• Product Code: EYI
• Date Received: 2014-03-07
• Model Number: *
• Catalog Number: 2219
• Lot Number: 534
• ID Number: *
• Device Availability: Y
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ADDTO, INC.
• Manufacturer Address: 816 N KOSTNER AVE CHICAGO IL 60651 US 60651

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-03-07