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 Number44545
MDR Report Key44545
Date Received1996-10-18
Date of Report1996-08-30
Date of Event1996-08-14
Date Facility Aware1996-08-14
Report Date1996-08-30
Date Reported to Mfgr1996-08-30
Date Added to Maude1996-10-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDAVOL
Generic NameMILLER-ABBOTT TUBE
Product CodeFEF
Date Received1996-10-18
Model NumberTUBE MILLER ABBOTT 14F
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age11 YR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key45466
ManufacturerDAVOL INC
Manufacturer AddressPO BOX 75677 CHARLOTTE NC 28275 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1996-10-18

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