MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC COUNTERFEIT MESH SLING; STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR

Device Problems Product Quality Problem (1506); Patient Device Interaction Problem (4001)

Patient Problems Autoimmune Disorder (1732); Bacterial Infection (1735); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/19/2016

Event Type  Injury  

Event Description

I'm a survivor of the boston scientific counterfeit mesh scam.As you are well aware, when bs ran out of materials in the u.S.For their mesh they illegally smuggled in counterfeit plastic resin from china.It almost killed me, and i would like some answers.My medical records "disappeared", i had to fight to get it removed (after it was pulled from market), no one notified me, i was diagnosed with an incurable autoimmune disease, the removal surgery nearly killed me, i lost half the blood in my body, ended up with a hematoma the size of a tennis ball on my bladder, it got infected with enterococcus, i was on iv antibiotics for weeks, and had a drain put in my stomach that i also lived with for weeks.I had a baby at home, i dropped my individual lawsuit to go public with my story, and am conducting my own private investigation for a book i'm currently writing.How in the profanity did this happen in the united states of america and why weren't the victims notified once you were made aware of this highly criminal an inhumane activity?.

• Brand Name: BOSTON SCIENTIFIC COUNTERFEIT MESH SLING
• Type of Device: STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16683654
• MDR Text Key: 312893241
• Report Number: MW5116333
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CBD; QUERCETIN WITH BROMELAIN; TURMERIC
• Patient Outcome(s): Other; Hospitalization; Life Threatening; Disability; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White