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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

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CODMAN & SHURTLEFF, INC. Back to Search Results
Catalog Number UNK VALVE
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
Udi -- unknown part number, attempts to obtain product were unsuccessful, udi unavailable. Multiple attempts to obtain additional information were not successful. Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
It was reported from biomarin, that after implant of a codman rickham device, there was an unknown malfunction and the device was revised. The patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device). The subject had his bmn 250 administration; however, during the administration of bmn 250, extravasation of study drug was observed and only 15 milligrams of bmn 250 was administered. The lot number and model number were not reported. The device was unable to be removed for an unreported reason and a new rickham icv device was implanted into the other lateral ventricle. The reporter assessed the event of device malfunction as related to the icv device. No other etiological factors were suspected. Additional information has been requested and, if received, the report will be updated.
 
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Brand NameNI
Type of DeviceNI
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8159513
MDR Text Key130178452
Report Number1226348-2018-10875
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK VALVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
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 Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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