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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MESH, SURGICAL, POLYMERIC

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BOSTON SCIENTIFIC CORPORATION MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Urinary Incontinence (4572)
Event Date 07/17/2017
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The voluntary user medwatch number is mw5103239. The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a vaginal sling was implanted into the patient during a procedure performed on (b)(6) 2005 to treat urinary incontinence. After the procedure, the patient started to have urinary tract infection and painful sexual intercourse. She went to a specialist to report the symptoms that she is experiencing. Reportedly, the patient was diagnosed with a urethral fistula. According to the patient, the implanted mesh caused the infection, fistula formation, inflammation, scar tissue formation, organ perforation, painful sexual intercourse, vaginal bleeding, chronic pelvic nerve damage and pain. The patient also received nerve blockers and pain management. On (b)(6) 2017, the vaginal sling was removed. During the procedure, after the sling was removed, the surgeon took a skin from the patient's leg to make a sling for the patient's bladder. Reportedly, the patient had a worsening urinary incontinence after the surgery. Subsequently, the patient have suffered from emotional pain and mental anguish while she is recovering from pain and for only having pain medications until she could no longer stand the pain. The patient went back to the emergency department to report the pain and she was given morphine and percocet to alleviate the pain and the nurse removed the sutures from the patient's leg.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12539831
MDR Text Key273556039
Report Number3005099803-2021-05012
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 Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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