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Adverse Event Report

BALLARD MEDICAL PRODUCTS MIC-G GASTROSTOMY TUBE   back to search results
Model Number 0100-22
Device Problem Tears, rips, holes in device, device material
Event Date 04/27/2002
Patient Outcome  Hospitalization;
Event Description

Pt had g tube inserted. Presented to er the next day with malfunctioning tube causing the tube to come out. Upon inspection of tube, it was identified that the balloon had a vertical split down the entire length of the balloon & causing it to deflate. Physician had not tested balloon prior to insertion-unsure if present prior to insertion.

 
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Brand NameMIC-G
Type of DeviceGASTROSTOMY TUBE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BALLARD MEDICAL PRODUCTS
12050 lone peak parkway
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
12050 lone peak parkway
draper UT 84020
Device Event Key382024
MDR Report Key392996
Event Key371267
Report Number392996
Device Sequence Number1
Product CodeKNT
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/06/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2002
Is This An Adverse Event Report? No
Device Operator Health Professional
Device EXPIRATION Date11/01/2002
Device MODEL Number0100-22
Device LOT Number83479
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/27/2002
Event Location Home
Date Report TO Manufacturer05/06/2002
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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