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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH
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MESH Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Wrinkled (2614)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348)
Event Date 05/20/2014
Event Type  Injury  
Event Description
I was operated on in (b)(6) on the (b)(6)2014.I had a problem after my babies deliverance.This is why the gynecologist (b)(6) suggested operation.She forgot to tell me about problems of the medical net set to my gynecological area.She said she made a mistake by setting the y-net to my gynecological area, so that it ripped my bladder, a big hole and the other bladder tube for urine.I was operated again (b)(6) and helping urologist cut my bladder together and made a new place for the tube.I was horribly ill with catheter and pain.New operation (b)(6) and found that one stitch was out, and bleeding, infected.The net was wrinkled and caused the pain.Still the pain is not over.Horrible pain in intercourse and now feels that the original symptoms are back.(loose inside).So these nets are not a very good idea for repairing these problems.Warn people and please ask countries to make a brochure to give out for information about the problems.Later, after the problems i found one research: (b)(4) i shall be tested for urinary things, bladder scan etc (has to go to toilet every 15 min) and gynecologist will look at my places again next week.My life went worse after that.I didn't know about the risks.
 
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Brand Name
MESH
Type of Device
MESH
MDR Report Key4454470
MDR Text Key5428308
Report NumberMW5040406
Device Sequence Number1
Product Code FTL
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/20/2015
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age55 YR
Patient Weight73
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