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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP PROGRIP MESH, SURGICAL, POLYMERIC

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COVIDIEN LP PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number LPG1510AL
Device Problems Material Puncture/Hole (1504); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  malfunction  
Event Description
A 15 x 10 cm piece of parietex progrip mesh that was anatomically shaped was folded, marked, moistened and inserted. It was then deployed, centering it on the hernia defect. We noted a hole in the mid portion of the mesh at the seam. The mesh was removed and held. A new piece was opened and placed in the same manner. The mesh laid nicely in place.
 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key8260423
MDR Text Key133528555
Report Number8260423
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberPRK1463X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2018
Event Location Hospital
Date Report to Manufacturer01/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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