BAROBAG NDC 0224-0066-12 1110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-18 for BAROBAG NDC 0224-0066-12 1110 manufactured by E-z-em, Inc.

Event Text Entries

[86] Patient received barium enema, patient stated later that day while at home that she had a reaction to the barium, faced swelled and lips swelled, and she broke out into large hives. Physicians prescribed benadryl. We feel that either the barium or the bag in which the barium was contained may be the cause of this illiness and that if this were used again for this patient more serious illliness may recur due to an anaphylactic type of reactiondevice labeled for single use. Patient medical status prior to event: fair condition. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other. Results of evaluation: invalid data, invalid data, invalid data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 109
• MDR Report Key: 109
• Date Received: 1992-03-18
• Date of Report: 1992-03-09
• Date of Event: 1992-03-02
• Date Facility Aware: 1992-03-02
• Report Date: 1992-03-09
• Date Reported to FDA: 1992-03-09
• Date Reported to Mfgr: 1992-03-05
• Date Added to Maude: 1992-03-26
• 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: BAROBAG
• Generic Name: BARIUM ENEMA BAG
• Product Code: FCD
• Date Received: 1992-03-18
• Model Number: NDC 0224-0066-12
• Catalog Number: 1110
• Lot Number: 43845
• Device Expiration Date: 1992-03-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-FEB-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 107
• Manufacturer: E-Z-EM, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-03-18