MAUDE Adverse Event Report: SURGICAL GLUE

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 08/30/2016

Event Type  Injury  

Event Description

I had a spinal stimulation implant put in my back on (b)(6) 2016 with in a week it developed an infection, and around (b)(6) 2016 they took it out and i spent a week in the hospital fighting the infection, and since (b)(6) still around (b)(6) the incision site would not heal and they went back in and cleaned the incision site to close the wound left from the incision.The hole in my back left from the incision still hasn't healed and will be going on (b)(6) 2017 to have it cleaned to try to get it healed.I spoke to the doctor who has been treating me and did the surgeries he stated that my infection came from the surgical glue from the original surgery to put the implant in and that he used the glue on 5 people and 4 ended up with infections.How do i find out which glue was used and if it was specific to just one lot or if there is multiple lots from the marker.My main concern is that other people do not have to go through what i am going through.

• Brand Name: SURGICAL GLUE
• Type of Device: SURGICAL GLUE
• MDR Report Key: 6639657
• MDR Text Key: 77653323
• Report Number: MW5070400
• Device Sequence Number: 1
• Product Code: MUQ
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 112