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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 Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: w/hook needle (lot# sfl00436); ugykp uretexto2 uretex sup pp transobtur2kit(lot# zga00163). This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect. Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form. 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 pelvic prolapse and stress incontinence. It was reported that after implant, the patient experienced recurrent stress urinary incontinence, cystocele (prolapse), mesh extrusion, pain, erosion, infection, unspecified urinary problems, dyspareunia, acute cystitis, hematuria, atrophic vaginitis, exposure of vaginal mesh into vagina, incontinence of feces, sexual dysfunction, recurrent uti's, urinary frequency, and vaginal bleeding. Post-operative patient treatment included additional surgical interventions.
 
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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 Key9639021
MDR Text Key189734001
Report Number9617613-2020-00022
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
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number482027
Device Catalogue Number482027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
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: 01/28/2020 Patient Sequence Number: 1
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