MAUDE Adverse Event Report: AMERICA MEDICAL SYSTEM/ BOSTON S SPARC SLING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Sepsis (2067); Myalgia (2238); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 09/02/2009

Event Type  Injury  

Event Description

Slowly, very painfully, debilitating me.I stay sick in severe debilitating chronic pain, unable to sit, walk, stand.Permanent nerve and muscle damage and pain.Device has twisted my pelvic bones, tilted forward twist right.Fall risk, septic from chronic infection.Device needs to be removed from market and recalled.

• Brand Name: SPARC SLING
• Type of Device: SPARC SLING
• Manufacturer (Section D): AMERICA MEDICAL SYSTEM/ BOSTON S
• MDR Report Key: 6653097
• MDR Text Key: 78063734
• Report Number: MW5070508
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/16/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 26 YR
• Patient Weight: 64