MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS MONARC SLING SYSTEM

Catalog Number 1006229

Device Problem Malposition of Device (2616)

Patient Problems Muscle Spasm(s) (1966); Tissue Damage (2104); Physical Entrapment (2327); Disability (2371); Ambulation Difficulties (2544); Test Result (2695)

Event Date 08/11/2015

Event Type  Injury  

Event Description

I had a monarc tot bladder mesh implant (b)(6) 2015.The mesh tape ended up sitting against my adductor tendon.It contracted my leg muscles so much that i had to have it removed asap 12 weeks after implanted.My muscles had gotten so contracted that when the mesh was released on (b)(6) 2015, several muscles tore in my upper left leg.I felt it as soon as i woke up from the surgery.And my muscles will not heal.I still can't get around without aid (crutches, wheelchair).I cannot walk.I am disabled now.Neurontin, oxycodone as needed, tramadol as needed.These are all because of the mesh complication.I was on no medications prior to this.

• Brand Name: MONARC SLING SYSTEM
• Type of Device: MONARC SLING SYSTEM
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS
• MDR Report Key: 5347281
• MDR Text Key: 35242342
• Report Number: MW5058897
• 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: 01/03/2016

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?: No
• Device Operator: No Information
• Device Expiration Date: 11/05/2017
• Device Catalogue Number: 1006229
• Device Lot Number: 910325
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 55