MALONEY BOUGIE 48,50 2150-48, 2150-50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for MALONEY BOUGIE 48,50 2150-48, 2150-50 manufactured by Pilling.

Event Text Entries

[2105] The patient had outpatiented esophageal dilation performed on december 5, 1991 at 10:10 a. M. Physician used b=new modified pilling maloney bougie. Second bougie met resistance but passed readily after the 3rd attempt. The device was not forced. The patient was discharged at d12:45 p. M. On december 5, 1991. The patient returned to the emergency room at 6:00 p. M. Complaining of severe lower chest/epiglastic pain and temperture of 102. 6f. Patient was admitted and treated surgically for esophageal tear. He was subsequently discharged on december 13, 1991device 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2868
• MDR Report Key: 2868
• Date Received: 1992-07-09
• Date of Report: 1992-03-19
• Date of Event: 1992-02-05
• Date Facility Aware: 1992-03-17
• Report Date: 1992-03-19
• Date Reported to FDA: 1992-03-19
• Date Reported to Mfgr: 1992-03-18
• Date Added to Maude: 1993-03-31
• 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: MALONEY BOUGIE
• Generic Name: DILATOR
• Product Code: KCD
• Date Received: 1992-07-09
• Model Number: 48,50
• Catalog Number: 2150-48, 2150-50
• Device Expiration Date: 1995-04-01
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-AUG-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2689
• Manufacturer: PILLING

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-09