MAUDE Adverse Event Report: AMS MONARC SUB FASCIAL SLING

Device Problem Degraded (1153)

Patient Problems Autoimmune Disorder (1732); Hepatitis (1897); Inflammation (1932); Nerve Damage (1979)

Event Date 12/23/2009

Event Type  Injury  

Event Description

Mesh eroded my vagina, autoimmune hepatitis, chronic inflammation, nerve damage to groin region.

• Brand Name: MONARC SUB FASCIAL SLING
• Type of Device: MONARC SUB FASCIAL SLING
• Manufacturer (Section D): AMS
• MDR Report Key: 3761541
• MDR Text Key: 4466089
• Report Number: MW5035718
• Device Sequence Number: 1
• Product Code: OTN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/15/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 86