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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-1707
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 10/14/2016
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed. Device discarded.
 
Event Description
Physician claim is that the catheter is not visible with imaging. The clinician is questioning whether or not the product is radiopaque. Device discarded. Per rep: "i was really limited in the information that i received. Unfortunately, i can't answer the follow questions with certainty. There was no serial number provided. However, i did receive additional information yesterday that indicated that the patient was over 400lbs and that may have contributed to the inability for the radiologist to see the catheter with x-ray. Apparently, the next patient she attempted to view under x-ray, she had no problem. ".
 
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Brand NameCODMAN LUMBER CATHETER KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6089359
MDR Text Key59506514
Report Number1226348-2016-10779
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964923
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-1707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2016
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

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