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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PML
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Type  Injury  
Event Description
Became very ill. Hospitalized for severe infection, auto immune disorder, pain with sex, abdominal swelling and pain, surgery to remove, but couldn't or i'd lose major organs, colon, rectum, bladder and vagina, bladder dead, self catheter, monthly infections. Complications. Fda safety report id# (b)(4).
 
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Brand NamePROLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON, INC.
MDR Report Key8612696
MDR Text Key145272538
Report NumberMW5086657
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 Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/11/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPML
Device Catalogue NumberPML
Device Lot NumberQME74B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 05/14/2019 Patient Sequence Number: 1
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