MAUDE Adverse Event Report:; MID URETHRAL SLING

Device Problems Material Erosion (1214); Explanted (1217)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/23/2017

Event Type  Injury  

Event Description

The patient underwent a bladder repair and a mid urethral sling in 2010.She recently started having some vaginal bleeding and was found to have mesh erosion on the right side to the urethra.The eroded mesh was removed.

• Brand Name: UNK
• Type of Device: MID URETHRAL SLING
• MDR Report Key: 6764684
• MDR Text Key: 81788635
• Report Number: 6764684
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2017
• Distributor Facility Aware Date: 06/23/2017
• Device Age: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 73