DAVOL TUBE MILLER ABBOTT 14F *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-18 for DAVOL TUBE MILLER ABBOTT 14F * manufactured by Davol Inc.

Event Text Entries

[27175] Mechanical obstruction and distention secondary to hyperinflated tube balloon. Bowel resection required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 44545
• MDR Report Key: 44545
• Date Received: 1996-10-18
• Date of Report: 1996-08-30
• Date of Event: 1996-08-14
• Date Facility Aware: 1996-08-14
• Report Date: 1996-08-30
• Date Reported to Mfgr: 1996-08-30
• Date Added to Maude: 1996-10-28
• 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: 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

• Brand Name: DAVOL
• Generic Name: MILLER-ABBOTT TUBE
• Product Code: FEF
• Date Received: 1996-10-18
• Model Number: TUBE MILLER ABBOTT 14F
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 45466
• Manufacturer: DAVOL INC
• Manufacturer Address: PO BOX 75677 CHARLOTTE NC 28275 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-10-18