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Adverse Event Report

CODMAN AND SHURTLEFF, INC. PERFORATOR   back to search results
Event Date 08/01/2003
Event Description

The perforator did not stop once the burr hole was accomplished. It perforated the dura but not the brain.

 
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Brand NamePERFORATOR
Type of DevicePERFORATOR
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CODMAN AND SHURTLEFF, INC.
325 paramount dr
raynham MA 02767
Manufacturer (Section D)
CODMAN AND SHURTLEFF, INC.
325 paramount dr
raynham MA 02767
Device Event Key489237
MDR Report Key500469
Event Key474595
Report Number500469
Device Sequence Number1
Product CodeKAT
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/01/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 12/03/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE,

Database last updated on February 28, 2009

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