UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-05 for UNK manufactured by .

Event Text Entries

[5465686] I was scheduled to have an endoscopic retrograde cholangiopancreatography, after the procedure i developed e. Coli septicemia and acute pancreatitis. This was back in 2001, but i am however wondering if this has been going on longer than recent news has reported. At the time the doctor had attempted to use a new (to him) device and a medical salesman was in the room at the time of my procedure. I believe he could not achieve this goal and used the old device, i don't know which tool (the new or the old one) introduced the e. Coli into my system. I spoke to a woman named (b)(6) from my area that works for the fda and she suggested i contact the agency through this method. I am not sure if it matters at all but as i stated before i don't think this is a new problem for these devices. I still have my medical records from this event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5041373
• MDR Report Key: 4603327
• Date Received: 2015-03-05
• Date of Report: 2015-03-05
• Date Added to Maude: 2015-03-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNK
• Generic Name: UNK ENDOSCOPIC DEVICE.
• Product Code: ODD
• Date Received: 2015-03-05
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2015-03-05