MAUDE Adverse Event Report: VAGINAL MESH IMPLANT ; MESH, SURGICAL, TRANSVAGINAL, SLING

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 02/27/2020

Event Type  Injury  

Event Description

Had a vaginal sling implanted.Woke up in severe pain in left hip and groin.I was unable to walk, lift my leg or urinate correctly.Md thought it was positioning in stirrups.With lots of pain medications.Mri's and xrays, 5 days later it is determine the sling is causing the problem and i can either have it removed or the nerves cut.I'm planning on having it removed tomorrow.Had a nerve block that determined somehow a nerve was involved.Fda safety report id# (b)(4).

• Brand Name: VAGINAL MESH IMPLANT
• Type of Device: MESH, SURGICAL, TRANSVAGINAL, SLING
• MDR Report Key: 9800956
• MDR Text Key: 182891642
• Report Number: MW5093590
• 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: 03/03/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 75