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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCHERING-PLOUGH CUSHION GRIP ORAL PASTE

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SCHERING-PLOUGH CUSHION GRIP ORAL PASTE Back to Search Results
Event Date 04/11/2005
Event Type  Death  
Manufacturer Narrative

 
Event Description

A lawyer reported a female consumer used cushion grip and orafix. He reported as a results she sustained severe, permanent and disabling injuries including acute myelogenous leukemia from which she died in 2005. No additional info was provided.

 
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Brand NameCUSHION GRIP
Type of DeviceORAL PASTE
Manufacturer (Section D)
SCHERING-PLOUGH
miami lakes FL
Manufacturer (Section G)
SCHERING-PLOUGH
13900 nw 57th court
miami lakes FL 33014 310
Manufacturer Contact
3030 jackson ave.
memphis , TN 38151
9013202421
MDR Report Key1036866
Report Number1020060-2007-00001
Device Sequence Number1
Product CodeKOP
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/21/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/06/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/21/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/06/2008 Patient Sequence Number: 1
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