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U.S. Department of Health and Human Services


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Lot Number
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Scar Tissue (2060); Swelling (2091); Thrombus (2101); Urinary Retention (2119); Burning Sensation (2146); Hematuria (2558)
Event Type  Other  
Event Description
I am writing because i am deeply upset and need to express my concerns and extreme dissatisfaction regarding my care provided by dr. (b)(6) at (b)(6). I am hoping that this letter will be enough to launch an investigation so it may prevent others from having to go through what i did and now have to live with. I became dr. (b)(6) pt back in 2008, chief complaint was urinary problems. I was diagnosed with stress incontinence. In (b)(6) of 2010 she started a series of collagen injections to treat this problem. Injections were given on 6 different dates: (b)(6) 2010, (b)(6) 2011, and considered one day surgical procedures. I saw no benefit or improvement so the other option she told me about was insertion of a pubovaginal sling. Dr. (b)(6) performed the surgery on (b)(6) 2014 at (b)(6)medical center. I stayed overnight and next day was sent home with a prescription. Once home and more alert, i realized the script was for hydro cordon. My chart clearly states i have an allergy to this medicine but this was overlooked by dr. (b)(6). I called to let them know and a different script was given. I experienced burning sensation, blood with catheterization, lower abdominal pain and bloating. On a return visit, dr. (b)(6) felt the sling might be too tight so she recommend i go in for a second surgical procedure called indwelling foley catheter placement due to the chronic retention of urine. Surgery was performed on (b)(6) 2014. Prior to the second procedure i once again reminded the nurses that i was allergic to the medication hydro cordon so they placed an alert tag on my operating room gown. I was told i would stay overnight but instead i was released later that day. I remained in the recovery room for 2 1/2 hrs then taken to another room where my husband was able to visit. I was extremely drowsy, slurring my words, etc. , that concerned my husband so he asked what they had given me for pain meds, they said vicodin. That is when my husband said that vicodin is in the same class family of hydrocodon and i am not to be given that. The nurse went out of the room to ask about it later to return and admit he was right but by that time it was too late, i had been given the meds via iv drip. I was in no condition to leave the hospital and my husband voiced his concern as well but they seemed to be in a hurry to leave as i was the last pt of the day to be discharged (5:15) lights had been turned off and discharge papers were handed out regardless of the fact that it took 2 nurses to help me get dressed. I was having a hard time waking up, i experienced chest pain, was very weak and dizzy. I experienced pain on the right side of my rib and had difficulty breathing yet they released me even though i told them i wasn't stable and didn't feel right and clearly could not walk on my own. My husband took me home after the nurses checked with dr. (b)(6) who told them i was to be released. I had a f/u visit to remove the packing in her office. I sat in the room for over an hour waiting for her to come in after triage completed their questions, i felt very weak and sickly but i waited patiently thinking i would have a chance to ask questions regarding my concerns. Once the dr finally came in, she appeared rushed and standoffish. I needed answers but when i tried to ask her anything she ignored my questions. I never had the chance to discuss anything with her. She had a cold attitude, was dressed in jogging clothing, (very unprofessional i might add) and told me to drop my drawers. I tried to explain how i was given the wrong meds etc but she ignored that. After the packing was out she said i will see you on monday to take the foley out and began to walk away. I was taken back by how she didn't seem to show any concern so i said "is that it?" yup she replied, i then said "but i still can't urinate, she told me to just continue to self cath and then walked away. I felt insulted, was upset with her attitude and felt extremely neglected. Before the first surgery, i could eliminate on my own, after the surgery i had to use a catheter to relieve myself, clearly i had a reason to be very upset and the right to have my questions answered in a professional manner. This whole experience has left me feeling self conscious, shame, frustrated and isolated from friends and family. The second surgery was suppose to reduce the tension on the sling but that surgery also went wrong. I had to continue to self catheter. I once again tried to get answers from dr. (b)(6) but this didn't seem to worry her at all and was told to continue to use the manual method to relieve myself along with wearing pads and undergarments. This was very upsetting to hear. From (b)(6), i had to go to the er 3 different times. Prior to the er visit, i attempted to get an appt to see her only to find out i couldn't get in for an appt, so had to resort to go to the er. Once again i was upset and felt neglected by this dr who didn't seem to care or be concerned with my problems. I strongly feel she messed up the surgery and now i have to deal with the consequences. After much frustration, pain and discomfort, i decided to get a second opinion and ultimately a third dr. (b)(6), md examined me on (b)(6) 2014 and said it appeared the sling had been removed but dr. (b)(6) told me she did not remove it. Test also found i had blood in my urine, blood clots, catheter infection, blood in foley. The catheter was replaced and i was put on more antibiotic. On another visit to dr. (b)(6) i brought in a piece of gauze that i had found on my pad. I had to continue to self cath, and was found to have a staph infection for which i was prescribed more medication. The infection lasted for months with 9 antibiotic prescribed during that time. When i reached a point where dr. (b)(6) felt he had little options left to offer me; i felt it was necessary to seek a specialist in the (b)(6) area 4 hrs away from home. I felt i needed answers and having to wear undergarments and self cath for life was not something i was willing to cope with. (b)(6) 2015 i saw drs (b)(6). I am currently under their care and will remain their pt until this matter is resolved. They are wonderful caring physicians that have given me a sense of professional knowledge, security and understanding for which i lacked with dr. (b)(6). After a comprehensive interview with me, dr. (b)(6) felt it was necessary to further examine me in the hospital. On (b)(6) 2015 i was examined in the operating room by dr. (b)(6). It was found that i had bladder damage from the multiple sling surgeries, scar tissue and bulging urethra swelling. The dr cannot see the sling that dr. (b)(6) insists is still there (she told me that on the second surgery she cut and tied the sling. ).
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Type of DeviceMESH
Manufacturer (Section D)
MDR Report Key6050370
MDR Text Key58317025
Report NumberMW5065549
Device Sequence Number3
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number
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