ULTRA-R BARIUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-25 for ULTRA-R BARIUM manufactured by E-z-em Co..

Event Text Entries

[21249547] Thept was scheduled for a ugi and small bowel series on 5/4/95. He had a history of reflux, copd, pneumonia, tb-mai in 1994. During the ugi he had a small amount of coughing, but did not appear to have aspirated the barium. Subsequent abdominal films for the small bowel series showed there was a medium amount of barium in the bronchial tree, lower lobes, apparently due to aspiration. The pt was monitored for 2 and 1/2 hours following the procedures and had no distress or change in vital signs. The pt developed pneumonia/ards and subsequently died on 5/12/95. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 25000
• MDR Report Key: 25000
• Date Received: 1995-07-25
• Date of Report: 1995-07-20
• Date of Event: 1995-05-04
• Report Date: 1995-07-20
• Date Reported to FDA: 1995-07-20
• Date Added to Maude: 1995-08-23
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 0
• 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: ULTRA-R BARIUM
• Generic Name: ULTRA-R BARIUM
• Product Code: FCE
• Date Received: 1995-07-25
• Lot Number: UR4008B, 4008A
• Operator: OTHER
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 25438
• Manufacturer: E-Z-EM CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1995-07-25