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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH SURGICAL MESH

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COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH SURGICAL MESH Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Swelling (2091); Thrombus (2101); Urinary Retention (2119); Burning Sensation (2146); Discomfort (2330); Hematuria (2558); Abdominal Distention (2601)
Event Type  Injury  
Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to the available information medwatch 5065549 - chief complaint was urinary problems. Patient was diagnosed with stress incontinence. Insertion of a pubovaginal sling dr. (b)(6) performed the surgery on (b)(6) 2014 at (b)(6) medical center. 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. I had a f/u visit to remove the packing in her office. I then said "but i still can't urinate, she told me to just continue to self cath and then walked away. 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 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. 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. 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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Brand NameUNKNOWN FEM PELVIC HEALTH MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6101974
MDR Text Key59896680
Report Number2125050-2016-00361
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/15/2016 Patient Sequence Number: 1
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