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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL COOK MEDICAL HERCULES 3 STAGE BALLOON

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WILSON-COOK MEDICAL COOK MEDICAL HERCULES 3 STAGE BALLOON Back to Search Results
Lot Number W3485909
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 02/17/2015
Event Type  Malfunction  
Event Description

After pt's duodenal and esophagus dilation with cook balloon dilator 10-11-12, physician stated it caused some trauma to hiatal hernia sac. Pictures printed and showed to cook rep (b)(6) and endo mgr.

 
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Brand NameCOOK MEDICAL
Type of DeviceHERCULES 3 STAGE BALLOON
Manufacturer (Section D)
WILSON-COOK MEDICAL
4900 bethania station rd
winston-salem NC 27105
MDR Report Key4643363
MDR Text Key19312985
Report NumberMW5041673
Device Sequence Number1
Product Code KNQ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2017
Device LOT NumberW3485909
OTHER Device ID NumberREF# G31925
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

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