MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. SPARC SLING; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Event Description

Became very ill.Hospitalized for severe infection, auto immune disorder, pain with sex, abdominal swelling and pain, surgery to remove, but couldn't or i'd lose major organs, colon, rectum, bladder and vagina, bladder dead, self catheter, monthly infections.Complications.Fda safety report id# (b)(4).

• Brand Name: SPARC SLING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 8612696
• MDR Text Key: 145272538
• Report Number: MW5086657
• Device Sequence Number: 3
• Product Code: FTL
• 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: 05/11/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Weight: 59