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Device Problem Migration or Expulsion of Device (1395)
Patient Problems Failure to Anastomose (1028); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994)
Event Date 04/23/2013
Event Type  Injury  
Event Description

I had surgery in (b)(6) 2013 for a rectal prolapse, 12 inches of colon removed, appendix removed, and bladder repair by two different surgeons. The gastro surgeon used staples and a week later, the area in my colon came apart and i had to be admitted for an ileostomy as i developed an abdominal infection. Further, the staples in my rectum were bothersome as if they were in to nerves. Later, i changed surgeons for an ileostomy reversal in (b)(6) 2013. Staples were used and the pain was horrible like a cactus sticking inside my abdomen. Further, i told her about the pain in my rectum and she said it would get better, but sent me to a gastroenterologist for a coloscopy to see what was going on. I was told that the staples were "sticking out" so that my stools were getting caught up in them causing "sores" on my colon/rectum. The staple problem continued to get worse and i spoke to my pc about it several times. He told me that he would get me into see another gastroenterologist. In the interim, i became terribly sick. Couldn't walk, move, or anything as i had spasms from head to toe and had no idea what was going on and wen to an er in nashville where i waited for over 3 hrs to see someone. I was given pain meds and sent home after the doc berated me. Still unable to walk without "charley horse" type spasms from head to toe and in horrible pain, i went to my pc who sent me for an mri. I was rushed to another er for surgery as i had an infection in the cauda equina, which i was told was extremely rare and dangerous. I had surgery and went through hell to say the least. I had to take iv antibiotics at home for 8 weeks and am still having problems. The doctors that worked on my case. Neurosurgeon, infectious disease doctor, and pc all agreed that the infection "probably came from the previous surgery" as i had not been out of the country nor had i suffered any back injuries. I don't know if the staples were the reason or human error, but at this time, the staples are still causing trouble in my abdomen and are much worse in the rectum, as some have popped out and stick my rectal area when i sit down in certain positions. I have now lost a good three years of my health and it seems that things are not getting much better.

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MDR Report Key5486253
MDR Text Key39936208
Report NumberMW5060788
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 03/03/2016 Patient Sequence Number: 1