CODMAN VARIABLE DEPTH DRILL GUIDE UNK NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-06 for CODMAN VARIABLE DEPTH DRILL GUIDE UNK NA manufactured by Johnson & Johnson Professional, Inc..

Event Text Entries

[205893] The tip of the guide broke off during the procedure and lodged in the spine, subsequently causing a laceration to the posterior wall of the esophagus, vocal cord paralysis, and damage to the vagal nerve. As a result of vagal nerve damage pt developed reflux esophagitis, "fits of aspiration," coughing and later bi-inguinal hernias. Device tip was surgically retrieved 2 days post-op. The mfr was served with a lawsuit and stated that they were never informed of the incident by the facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1017863
MDR Report Key257733
Date Received2000-01-06
Date of Report2000-01-06
Date of Event1997-11-21
Date Added to Maude2000-01-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCODMAN VARIABLE DEPTH DRILL GUIDE
Generic NameDRILL GUIDE
Product CodeHXY
Date Received2000-01-06
Model NumberUNK
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key249588
ManufacturerJOHNSON & JOHNSON PROFESSIONAL, INC.
Manufacturer Address325 PARAMOUNT DR RAYNHAM MA 02767 US


Patients

Patient NumberTreatmentOutcomeDate
10 2000-01-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.