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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; LIGATING CLIP
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TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; LIGATING 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 01/24/2015
Event Type  malfunction  
Event Description
Alleged issue: one clip was unable to close after application.It fell into the abdominal cavity.It was retrieved using grasping forceps.The pt is stable and recovering.
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review did not show issues related to complaint.The device sample has been returned to the mfr, however, the investigation results have not been submitted at the time of this report.The mfr will continue to monitor and trend relating complaints.
 
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Brand Name
HEMOLOK ML CLIPS 6/CART 84/BOX
Type of Device
LIGATING 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
doris sturgis, ra associate
3015 carrington mill blvd
morrisville, NC 27560
9194334953
MDR Report Key4563556
MDR Text Key5460770
Report Number3003898360-2015-00114
Device Sequence Number1
Product Code MCH
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date01/22/2019
Device Catalogue Number544230
Device Lot Number01A1400300
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/10/2015
Date Manufacturer Received01/27/2015
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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