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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; HEMOLOK CLIP
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TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; HEMOLOK CLIP Back to Search Results
Catalog Number 544230
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2015
Event Type  malfunction  
Event Description
Alleged event: the doctor found clips cannot be ligated correctly and doctor felt that the clips were softer than the ones he used before.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box, lot #73e1400403 investigation did not show issues related to the complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
 
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Brand Name
HEMOLOK ML CLIPS 6/CART 84/BOX
Type of Device
HEMOLOK CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 2147 8
MX   21478
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville, NC 27560
9194332672
MDR Report Key4824237
MDR Text Key5839508
Report Number3003898360-2015-00435
Device Sequence Number1
Product Code MCH
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/29/2019
Device Catalogue Number544230
Device Lot Number73E1400403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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