MAUDE Adverse Event Report: AMERICAN MEDICAL SOLUTIONS TRANSVAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 02/01/2016

Event Type  Injury  

Event Description

Transvaginal mesh serious complications which started approx (b)(6) 2016 which include pain during and without intercourse, vaginal bleeding and lower back pain.Fda safety report id# (b)(4).

• Brand Name: TRANSVAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): AMERICAN MEDICAL SOLUTIONS; 2222 w. parkside lane #114; phoenix AZ 85027
• MDR Report Key: 12751593
• MDR Text Key: 280475182
• Report Number: MW5105132
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/01/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White