500217

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-23 for 500217 manufactured by Lafayette.

Event Text Entries

[18441741] Patient had anaphalactic reaction towhat we suspect was the latex retension cuff on a barium enema tip. Medical intervention was required including the injection of epinephrine, solu-cortef, benadryl and oxygen. After treatment patient improved and was held for observation for about six hours before being discharged tohome. (e_z_em barosperse barium & bag were used in conjunction with enema tip. Product was not labeled as to contents or contraindicationsdevice not labeled for single use. Patient medical status prior to event: satisfactory 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. Imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: labeling - incomplete, unanticipated adverse reaction - short term. Conclusion: other. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device permanently removed from service. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 33534-1992-00001
• MDR Report Key: 1979
• Date Received: 1992-11-23
• Date of Report: 1992-11-16
• Date of Event: 1992-11-05
• Date Facility Aware: 1992-11-05
• Report Date: 1992-11-16
• Date Reported to FDA: 1992-11-16
• Date Reported to Mfgr: 1992-11-06
• Date Added to Maude: 1993-01-04
• Event Key: 0
• Report Source Code: Distributor 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: UNKNOWN
• 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

• Product Code: FGD
• Date Received: 1992-11-23
• Catalog Number: 500217
• Lot Number: 4391
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-FEB-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1843
• Manufacturer: LAFAYETTE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-23