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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 45 DEGREES LEFT SUTURE/NEEDLE PASSER, SINGLE-USE

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DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 45 DEGREES LEFT SUTURE/NEEDLE PASSER, SINGLE-USE Back to Search Results
Catalog Number 251003
Device Problem Separation Failure
Event Date 01/09/2019
Event Type  Malfunction  
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Brand NameIDEAL SUTURE SHUTTLE 45 DEGREES LEFT
Type of DeviceSUTURE/NEEDLE PASSER, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham , MA 02767
6103142063
MDR Report Key9124284
Report Number1221934-2019-58576
Device Sequence Number1
Product CodeHCF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number251003
Device LOT Number17R05
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 Received01/09/2019
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?
Type of Device Usage Unkown

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