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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PARIETEX MESH ABDOMINAL SURGICAL MESH

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MEDTRONIC PARIETEX MESH ABDOMINAL SURGICAL MESH Back to Search Results
Model Number PC012X
Device Problem Malposition of Device (2616)
Patient Problems Nausea (1970); Obstruction/Occlusion (2422)
Event Date 05/22/2018
Event Type  Injury  
Event Description
Pt had incisional hernia repair on (b)(6) 2018. Pt developed nausea and vomiting and was readmitted on (b)(6) 2018. Pt taken to operating room for exploratory laparotomy on (b)(6) 2018 where it was discovered that the mesh was placed with the protective barrier to the abdominal wall.
 
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Brand NamePARIETEX MESH
Type of DeviceABDOMINAL SURGICAL MESH
Manufacturer (Section D)
MEDTRONIC
minneapolis MN
MDR Report Key7625886
MDR Text Key111997947
Report Number7625886
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Model NumberPC012X
Device Lot NumberPRG0080X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2018
Distributor Facility Aware Date06/01/2018
Device Age NA
Event Location Hospital
Date Report to Manufacturer06/14/2018
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/15/2018 Patient Sequence Number: 1
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