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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; HEMOCLIP CLIP
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TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; HEMOCLIP 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 11/27/2014
Event Type  malfunction  
Event Description
Complaint alleges: it was reported that a surgery on a patient was being performed and the hem-o-lok clip did not tighten and fasten.The surgeon tried several times to use the clip, but was unsuccessful; he the used a different applier, still the problem remained.The surgeon was able to successfully complete the surgery after he used clips from a different lot number.Additional information was requested, but no additional information was received at the time of this report.There were no clinical consequences reported, as a result of the incident.
 
Manufacturer Narrative
The device sample was not received by the manufacturer at the time of this report.
 
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Brand Name
HEMOLOK ML CLIPS 6/CART 84/BOX
Type of Device
HEMOCLIP CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate, bc 2147 8
MX   21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4490998
MDR Text Key5327465
Report Number3003898360-2015-00110
Device Sequence Number1
Product Code MCH
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/23/2019
Device Catalogue Number544230
Device Lot Number73E1400184
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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