MAUDE Adverse Event Report: COVIDIEN/SOFRADIM PERMACOL; MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Twitching (2172)

Event Type  Injury  

Event Description

In 2011 i had a rhinoplasty.To have a satisfactory and stable result over the time the plastic surgeon decided to use permacol biological implant.In 2013 i started to have spasms in the nose and mouth area on my face.Since it's getting worst because it reached the eyes and all the faces now.Sometimes i also can feel micro movements around the eyes.I often got heavy eyelids and feel tired.It really worried me in (b)(6) 2014 because it began to get really worst at that time.But it started a few months earlier even though i didn't really pay attention on it.Because i thought it would stop soon.I've seen the neurologist.After a mri and an electroencephalogram he can't find anything.From that point i really start to suspect that there is a link between the permacol and the spasms.I would like to know, have you had any testimony like that before? do you think there might be a link between the permacol and my issue?.

• Brand Name: PERMACOL
• Type of Device: MESH
• Manufacturer (Section D): COVIDIEN/SOFRADIM
• MDR Report Key: 6311288
• MDR Text Key: 66876026
• Report Number: MW5067726
• Device Sequence Number: 1
• Product Code: FTL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 31 YR