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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 482047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Cyst(s) (1800); Purulent Discharge (1812); Edema (1820); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Intermenstrual Bleeding (2665); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4)) and is now being submitted on a 3500a form because of newly received information indicating this is a duplicate event. This event was previously submitted under regulatory report# 9617613-2013-01203. This file will be closed and any further updates will be processed under regulatory report# 9617613-2013-01203. 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 of urinary stress incontinence, pelvic pain, uterine descensus, dysmenorrhea, hypermenorrhea, bilateral polycystic ovaries, pelvic floor relaxation with symptomatic rectocele and enterocele. The procedures performed were total abdominal hysterectomy, bilateral salpingo-oophorectomy, anterior urethropexy, posterior repair and repair of enterocele with mesh. It was reported that after implant, the patient experienced the following conditions that they associated to the mesh: tenderness in the abdomen, edema of lower stitches, pelvic pain secondary to levator muscle band, urge incontinence, vaginal discomfort, enlarged bladder, left rectus muscle spasms, low sharp pain and greenish discharge, soreness on left side, low abdominal pain and incisional discomfort. Adhesions, dysuria, blood and mucous in stools, cyst on left flank, left chest wall mass, small bowel obstruction, dyspareunia, recur rent urgency, frequency, obstructive voiding, second degree cystocele, second degree rectocele, pelvic floor relaxation, pelvic organ prolapse, pressure/tension/pulling in pelvis area, stranguria, suprapubic pain, left groin pain, interstitial cystitis, hematuria, atrophic vaginitis, bladder pain, bladder infection, retention of urine, bright red vaginal spotting, uti, urethral obstruction, urethral dilation, chronic constipation, depression, and anxiety. The patient also has a mersa infection on the leg that will reappear any time a bladder/vaginal infection occurs. Treatment included laparoscopic lysis of adhesions, steroid injection, surgery involving incision/release of the levator muscle band, mesh revision/removal surgery (ten years after implant), and a laparoscopy.

 
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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 Key8413718
MDR Text Key138572302
Report Number9617613-2019-00009
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/30/2004
Device MODEL Number482047
Device Catalogue Number482047
Device LOT Number02A20B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
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: 03/12/2019 Patient Sequence Number: 1
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