MAUDE Adverse Event Report: AMS MONARC SUBFACIAL HAMMOCK

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Reaction (2414); Collapse (2416)

Event Type  Injury  

Event Description

I have a monarc subfascial hammock and along with typical mesh complications, which have been ignored, i began having neurological problems in (b)(6) 2012.Such as nerve pain in hands, wrists, neck so severe i had to quit my job at (b)(6).In (b)(6) i was diagnosed with fibromyalgia by a rheumatologist, without any testing being done.I have since seen a battery of dr's and done a ton of research on line.In the last month, i have begun having severe contortions of my legs and also collapsed about a week ago.I was researching the seizing of my legs and came across a lady with similar symptoms who had a metal allergy so i went to an allergist who has determined that i am severely allergic to palladium and also to molybdenum.I have been searching polypropylene and have learned that palladium is the catalyst used to form the covalent bond between the polymers that create the propylene and i contacted ams and they have agreed to send a sample so that i can have it tested to see if indeed it does contain palladium.In my search i have located several pts' stories that had the mesh and were later diagnosed with fibromyalgia but the two were never linked.If palladium particles are in the mesh and these people are allergic, as am i, then it could be from the palladium.I am trying to get help.I have to know if the mesh has palladium and i am hoping you can advise of where in (b)(6).I can take the sample for testing.Please help.Thank you, (b)(6).

• Brand Name: MONARC SUBFACIAL HAMMOCK
• Type of Device: MONARC SUBFACIAL HAMMOCK
• Manufacturer (Section D): AMS
• MDR Report Key: 3679706
• MDR Text Key: 4301616
• Report Number: MW5034935
• Device Sequence Number: 1
• Product Code: OTM
• 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: 03/10/2014

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 67