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Adverse Event Report

DORNIER MEDTECH SYSTEMS GMBH   back to search results
Event Date 01/23/1997
Event Type  Injury  
Manufacturer Narrative

Event known complication of lithotripsy which is believed to be attributed to pt's mobile spleen. Frequency addressed in label: no. Frequency greater than usual: unk. Severity addressed in label: no. Severity greater than usual: unk.

 
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Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section G)
DORNIER MEDTECH SYSTEMS GMBH
argelsrieder feld 7
wessling
GERMANY D-82234
Device Event Key86537
MDR Report Key87389
Event Key82215
Report Number9611388-1997-00003
Device Sequence Number1
Product CodeFFK
Report Source Manufacturer
Source Type Health Professional,Company Representative
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/1997
Date Manufacturer Received04/02/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1996
Is The Device Single Use? No
Is the Device an Implant? No
Type of Device Usage Unkown

Database last updated on February 28, 2009

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