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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC MESH BLADDER SLING
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BOSTON SCIENTIFIC MESH BLADDER SLING Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Shaking/Tremors (2515); Ambulation Difficulties (2544)
Event Date 01/11/2013
Event Type  Injury  
Event Description
Went in for simple bladder mesh surgery for sui.Immediately upon waking experience pain.Returned prior to 2 wk f/u because legs would not stop shaking uncontrollably.Dr informed me that the mesh had to come out, but that he had no experience in doing so.Several drs later found a urologist to do partial removal.Pain still persisted.Sent to another urologist for further removal.Mesh had migrated and cut through thigh muscle severing nerves.Pain still persists in all my lower extremities, making it unbearable to walk at times.I now have permanent nerve damage, muscle spasms, little or no control over my bladder functions and the inability to complete normal daily functions.
 
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Brand Name
MESH BLADDER SLING
Type of Device
MESH
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key7352186
MDR Text Key102918046
Report NumberMW5075965
Device Sequence Number1
Product Code PAH
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 03/16/2018
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 Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
1 A DAY VITAMIN ; ARMOURTHYROID; BACLOPHEN; BLOOD PRESSURE; GABAPENTIN; HYDROCODONE; IBUPROFEN; MAGNESIUM; MEDICAL MARIJUANA; MIGRAINE MED; NAPROXEN
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age38 YR
Patient Weight79
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