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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482212
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Flatus (1865); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Abdominal Cramps (2543); Hematuria (2558); Blood Loss (2597); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Occupation :attorney (atty). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Patient underwent mesh implant surgery for uterine prolapse, cystocele, rectocele. Procedure (s) performed were total vaginal hysterectomy and anterior and posterior repair. Patient experienced symptomatic rectocele, bulge in the vagina still having trouble with bulging from 2004 to 2007 and planned for posterior repair doing posterior repair and placement of avaulta. Complications post additional avaulta posterior mesh placement are in 2007 patient had frequent urination, burning during urination, urgency, dysuria, urinary tract infection, red brown stool, bladder infection better and epigastric pressure. In, 2008 - 2009: bulge in her vagina when she moves her bowels, on pelvic exam there is an enterocele and 1 degree cystocele. Rectocele has been completely obliterated. She also reported dysuria, frequency, urgency, hematuria, burning on urination and urinary tract infection. Complications post revision surgery from 2009 -2011 ecchymosis was noted around the colostomy region, bloody drainage, abdominal cramping, having green and brown sputum, constipation, burning when urinating, dysuria, urinary tract infection - the flexible sigmoidoscopy examination and put in a lot of air and none of that came into the vagina - the vaginal area does reveal some structuring - guarding in the rectal ampulla towards the vagina ¿ underwent colostomy on (b)(6) 2009 - xr barium enema complete on (b)(6) 2009 shows numerous diverticula throughout the sigmoid colon. Contrast material extends to mid transverse colon and on lateral view shows contrast communicating with ostomy and into the patient¿s ostomy bag. Tract contrast seen just below the suture line and it is uncertain whether th is portion of the colon was intentionally attached the ostomy and/or there has been development of interval fistulous tract to the ostomy - prescribed antibiotics. In, 2011 patient has difficulty in holding back flatus frequently at least more than once a week. On anorectal examination reveals small internal and external hemorrhoids. In 2012: patient has difficulty in holding back flatus frequently at least more than once a week - benign colon polyp. Planned for colonoscopy, possible biopsy or polypectomy. In, 2013: colonoscopy shows severe diverticulosis on sigmoid, poor sphincter tone and small hemorrhoids in rectum and anal canal. In, 2014: patient has benign polyp of colon. The flexible sigmoidoscopy examination reveals significant diverticulosis with some narrowing and fixation. Patient reassured. Continue the treatment plan. Follow-up in 1 year.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH TSL - PELVICOL¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7715663
MDR Text Key114896488
Report Number9617613-2018-00072
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number482212
Device Catalogue Number482212
Device Lot Number03B13B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/24/2018 Patient Sequence Number: 1
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