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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE Back to Search Results
Model Number RELTACK10R
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, when fixing the mesh into the abdominal cavity to cover the hernia defect during a laparoscopic umbilical hernia repair, the tacks did not penetrate the mesh properly and did not stay in place and emerged from the mesh.The surgeon had to remove all the tacks and used another reload to complete the fixation.There was no patient injury.
 
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Brand Name
RELIATACK
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key9203962
Report Number1219930-2019-05880
Device Sequence Number3058179
Product Code GDW
UDI-Device Identifier20884521202389
UDI-Public20884521202389
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K140609
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberRELTACK10R
Device Catalogue NumberRELTACK10R
Device Lot NumberM9A0975S
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date10/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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