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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES PELVICOL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482027
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Numbness (2415); Prolapse (2475); Ambulation Difficulties (2544); Hematuria (2558); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
(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. The product was used for therapeutic treatment of second degree cystocele. It was reported that after implant, the patient experienced uterine prolapse, vaginal and vaginal vault prolapse, stress urinary incontinence, with urethral hypermobility, right ureterolysis, abdominal enterocele, rectocele, cervical prolapse, pain, urinary problems, bowel problems, fistulae, recurrence, dyspareunia, recurrent cystocele, urinary tract infections, urinary retention, self-catheterization, nocturia, incomplete stool emptying, straining for urination, dribbling, hematuria, numbness in the left thigh and left vulva, perineal numbness, constipation, vaginal pain, difficulty initiating stream, bladder spasms, discomfort walking and standing due to fallen bladder, and vaginitis. Post-operative patient treatment included surgical and nonsurgical interventions, including hysterectomy.
 
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Brand NamePELVICOL
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 Key9260983
MDR Text Key166795997
Report Number9617613-2019-00182
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/09/2012
Device Model Number482027
Device Catalogue Number482027
Device Lot Number08B21-8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
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: 10/31/2019 Patient Sequence Number: 1
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