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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN/MEDTRONIC PROGRIP PARIETEX PROGRIP MESH

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COVIDIEN/MEDTRONIC PROGRIP PARIETEX PROGRIP MESH Back to Search Results
Lot Number SQK1250X
Device Problems Material Frayed (1262); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2017
Event Type  malfunction  
Event Description
During a surgical procedure requiring mesh, the surgeon surgically attached the mesh, and while testing the mesh (patient coughing) the mesh ripped and frayed. The mesh was removed and a different type of mesh was used, procedure completed. An event report was institutionally filed, the mfr was called, the sales rep was notified. Mesh was saved to be sent back to the company. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: hernia.
 
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Brand NamePROGRIP
Type of DevicePARIETEX PROGRIP MESH
Manufacturer (Section D)
COVIDIEN/MEDTRONIC
MDR Report Key6463271
MDR Text Key72125260
Report NumberMW5068923
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Lot NumberSQK1250X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/04/2017 Patient Sequence Number: 1
Treatment
PARIETX PROGRIP.
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