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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.
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CODMAN PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Device Problem Device Issue (2379)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Clutch didn't disengage properly.Surgeon turned off the drill.
 
Manufacturer Narrative
Gtin: unknown.Upon completion of the investigation, a follow up report will be filed.
 
Manufacturer Narrative
The product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.Device not available.
 
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Brand Name
CODMAN PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key4763428
MDR Text Key16176025
Report Number1226348-2015-10278
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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