MAUDE Adverse Event Report: ALTRIUM ATRIUM IMPLATE MESH PROLOOP; MESH, SURGICAL, POLYMERIC

Catalog Number 30901

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Dysuria (2684)

Event Date 09/14/2015

Event Type  Injury  

Event Description

I had hernia surgery (b)(6) 2015, and now having complications from the surgery.The symptoms are pain in the left side, unable to have sex, no appetite, severe pain on left side, area where surgery is red, unable to wear tight pants must be loose fitting, having pain during urination, unable to stand for anything over 5 minutes because of pain.

• Brand Name: ATRIUM IMPLATE MESH PROLOOP
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ALTRIUM
• MDR Report Key: 6345414
• MDR Text Key: 67954035
• Report Number: MW5067955
• Device Sequence Number: 1
• Product Code: FTL
• 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: 02/16/2017

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 Catalogue Number: 30901
• Device Lot Number: 10813702
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: ADVIL FOR PAIN. ; RX MEDS: NONE.
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Weight: 75