MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SUPRAPUBIC MIDURETHRAL SLING SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068503000

Patient Problems Autoimmune Disorder (1732); Dry Eye(s) (1814); Foreign Body Reaction (1868); Inflammation (1932)

Event Date 01/01/2014

Event Type  Injury  

Event Description

I had lynx suprapubic sling implant in 2012.Overall i am a healthy person.In 2014 i started to have body aches, inflammation, and dry eyes.Going through with a lot of doctor visits, and medication taking.No one could find out how i got this diagnosis autoimmune disease called sjogren.Finally doing more investigation on my health, i felt that all this came from the sling.Foreign object can cause inflammation and other health issues.I was told the sling that i got has been recalled.I would like to look into this issue and see if anyone had this health issue like me.

• Brand Name: LYNX SUPRAPUBIC MIDURETHRAL SLING SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 19184634
• MDR Text Key: 341203204
• Report Number: MW5154310
• 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: 04/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068503000
• Device Lot Number: ML00000321
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Patient Sequence Number: 1
• Treatment: ADVIL.; IBUPROFEN.; VITAMINS.
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White