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Adverse Event Report

COOK UROLOGICAL, INC.   back to search results
Event Date 02/22/1999
Event Type  Injury  
Manufacturer Narrative

The hosp would not return the balloon for eval. A co rep was allowed to view and photograph the balloon at the hosp. The info received from co rep and from viewing the photographs show a horizontal slit that appears to have occurred above the balloon's back band. This appearance is indicative of the balloon having been overinflated or having been inflated in a restricted area. These products are 100% quality control inspected at the co's facility.

 
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Baseline Brand NameOMEGA NV BALLOON URETERAL DILATION SET
Baseline Generic NameOMEGA URETERAL BALLOON
Baseline Catalogue Number078670
Baseline Device FamilyDILATOR AND DILATOR SETS
Baseline Device 510(K) NumberK813278
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed04/09/1985
Manufacturer (Section G)
COOK UROLOGICAL, INC.
1100 west morgan st.
spencer IN 47460
Manufacturer Contact
debbie schmitt
1100 west morgan street
spencer , IN 47460
(812) 829 -4891
Device Event Key217000
MDR Report Key223764
Event Key209997
Report Number1825146-1999-00008
Device Sequence Number1
Product CodeEZN
Report Source Manufacturer
Source Type User facility,Company Representative
Remedial Action Replace
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/1999
Date Manufacturer Received04/22/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? No
Type of Device Usage Unkown

Database last updated on February 28, 2009

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