MAUDE Adverse Event Report: MESH FOR BLADDER SLING

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 08/30/2006

Event Type  Injury  

Event Description

Original message from: (b)(6), sent: (b)(6) 2016 11:42 am, to: cdrh-osb-mdr policy response line, subject: bladder lift mesh.I had the bladder sling put in (b)(6) 2006.In (b)(6) 2015, i went to dr.(b)(6) (who has been my gyn for over 20 years) because i was having some pain and bleeding.He did a procedure in his office that day.The bleeding continued.I went back and he did another procedure.I was still having some pain and bleeding.The third time i went back his physician's assistant told me i needed surgery.I was referred to dr.(b)(6).She could feel mesh and she clipped it and stitched it up.I went back to her yesterday for my follow up and because i was still bleeding.The stitches had popped and she could feel pieces of the mesh.I am scheduled for surgery on (b)(6).I am trying to make sure this is not part of the mesh problems that need to be reported.(b)(6).

• Brand Name: MESH FOR BLADDER SLING
• Type of Device: MESH
• MDR Report Key: 5529223
• MDR Text Key: 41369279
• Report Number: MW5061282
• Device Sequence Number: 1
• Product Code: FTL
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 67