MAUDE Adverse Event Report: BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM; MESH

Model Number M006802110

Device Problem Unintended Movement (3026)

Patient Problems Incontinence (1928); Laceration(s) (1946); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Lethargy (2560); Abdominal Distention (2601); Dysuria (2684); Device Embedded In Tissue or Plaque (3165)

Event Date 09/08/2011

Event Type  Injury  

Event Description

Patient stated that after mesh was implanted on (b)(6) 2011, she felt sick, developed a uti and could not urinate to the point that she needed to exert force to be able to void.She is currently taking amitriptyline 25mg p.O for nerve damage.She is also experiencing "trigger point shot" and anesthesia is injected through her vagina for nerve pain.On (b)(6) 2012, a second surgery was performed due to mesh cutting through her vaginal walls.Half of the mesh was extracted, but the other portion remained in patient.The doctors said they could not do anything further for her, so she went for a second opinion.The remaining part of the mesh is now cutting through the abdominal walls.She is currently in the process of having a third surgery and is due for lab work friday (b)(6) 2015.She currently experiences abdominal distention, leg pain, hip pain, inability to urinate and has to wear diapers at all times.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlboro MA 01752
• MDR Report Key: 5088386
• MDR Text Key: 26245166
• Report Number: MW5056253
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/16/2015

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: No Information
• Device Model Number: M006802110
• Device Lot Number: ML00000197
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 68