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U.S. Department of Health and Human Services

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

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ETHICON INC. PROCLEAN FLAT MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number CJE467
Device Problems Break (1069); Crack (1135)
Patient Problems Pain (1994); Vomiting (2144)
Event Date 04/05/2019
Event Type  Injury  
Event Description
Had hernia surgery in 2011 and after a couple of years my teeth began to crack and break until i was toothless then eventually my stomach started having pains until i started vomiting all night every night until it became uncontrollable. I eventually was rushed to the hosp where they elected to do emergency surgery and found that the mesh had become gangrenous. I had an add'l surgery with the next week and was placed in medically induced coma for nearly 3 months and after they brought me back, i was in the hosp for an add'l 3 months. Eventually i got a fistula which resulted in 2 years of hospitalization and too much stress on my heart; finally after getting strong enough to finish my journey to getting better, i had 2 more surgeries this year as a result of this mesh. Fda safety report id# (b)(4).
 
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Brand NamePROCLEAN FLAT MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
MDR Report Key8604662
MDR Text Key145006661
Report NumberMW5086570
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2019
Device Model NumberCJE467
Was Device Available for Evaluation? No
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2019 Patient Sequence Number: 1
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