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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 Cyst(s) (1800); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Dysuria (2684); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint report: (b)(4).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.Reason for mesh implantation: very large cystocele, vaginal wall prolapse, rectocele and stress urinary incontinence.Procedures performed: cystoscopy, tension free suspension, anterior repair, exploratory laparotomy, gortex colposacral suspension.Concomitant implants (products used at the same time): gynecare tvt device.Complications post additional implant surgery: complains of vaginal bulging out and possible urinary tract infection (uti), pelvic pressure and odorous urine, dysuria, bleeding with intercourse, mild rectocele.Cystoscopy, vaginoscopy, examination under anesthesia revealed ¿bladder: has changes of cystitis cystica at bladder neck, orifices are normal.No stones, tumors, or foreign bodies were noted throughout the bladder.Cystitis, vaginitis, urinary tract infection, bladder spasm and increased pressure with micturition, malodorous urine, cloudy urine, dysuria and frequency.Pain since bladder repair, pelvic pain, dyspareunia and frequent urinary tract infections (uti), urinary incontinence, pelvic organ prolapse, post menopausal atrophic vaginitis, fecal incontinence.Interventional surgery: (b)(6) 2014: underwent cystoscopy and exam under anesthesia for incomplete emptying with history of multiple urethral slings under general anesthesia.Conditions post interventional surgery: bladder and pelvic pressure, incomplete emptying, micro hematuria, positive for urinary leakage, incomplete emptying, microhematuria and recurrent uti, stress incontinence, micro hematuria, urinary retention and benign neoplasm bladder.On (b)(6) 2015: underwent interstim percutaneous sacral nerve stimulation test with fluoroscopic guidance for needle placement.Repeat procedure on the opposite side of the sacral nerve for incomplete emptying and fecal incontinence under local anesthesia.Bladder pain.Assessed with incomplete emptying and bladder pain.
 
Manufacturer Narrative
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.The product was used for therapeutic treatment.The reason for mesh implantation was a very large cystocele, vaginal wall prolapse, rectocele and stress urinary incontinence.The procedures performed were cystoscopy, tension free suspension, anterior repair, exploratory laparotomy, gortex and colpo sacral suspension.The complications post additional implant surgery were urinary tract infection (uti), pelvic pressure, odorous urine, dysuria, bleeding with intercourse and mild rectocele.
 
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Brand Name
MESH TSL - PELVICOL¿
Type of Device
MESH, 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 Key7396755
MDR Text Key104361172
Report Number9617613-2018-00020
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 consumer
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2002
Device Model Number482047
Device Catalogue Number482047
Device Lot Number01A04B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/03/2016
Initial Date FDA Received04/04/2018
Supplement Dates Manufacturer Received07/05/2017
Supplement Dates FDA Received06/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age41 YR
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