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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 UNK PELVICOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Incontinence (1928); Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: the patient alleged injury. Patient underwent pelvicol reconstruction in 2006. Corresponding operative report is not available to know the details of the operation performed. Complications post pelvicol placement in 2006: recurrent stress incontinence and pelvic prolapse with a history of previous pelvicol reconstruction. Indirect information taken from the operative report. First additional implant surgery: 2006: underwent urethrolysis, sling, anterior repair, and sacrospinous fixation for recurrent stress incontinence and pelvic prolapse under general anesthesia complications post additional implant surgery: 2006: stress urinary incontinence and pelvic prolapse. (indirect information taken from the operative report; corresponding medical records are not available to substantiate these complications). Mesh revision surgery with second additional implant surgery: 2006: underwent sling, anterior repair, posterior repair and sacrospinous fixation of pelvic prolapse for stress urinary incontinence and pelvic prolapse under general anesthesia. Following mesh revision patient developed vaginal discharge, recurrent stress incontinence and pelvic prolapse during the time period from 2006 to 2007 and underwent the following surgeries. Interventional surgery: 2006: underwent cystoscopy, removal of foreign body and closure of vagina for history of pelvic prolapse with previous multiple procedures with vaginal discharge. Third additional implant surgery:2007: underwent sling, urethrolysis, anterior repair with graft, sacrospinous fixation and cystoscopy for recurrent stress incontinence and pelvic prolapse under general anesthesia. Concomitant therapy: pelvilace to trans-obturator biourethral support system with hook needle, uretex to2 urethral support system w/hook needle, pelvitex polypropylene mesh, avaulta posterior biosynthetic support system precision twist transvaginal anchor.
 
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 Key7745098
MDR Text Key115904289
Report Number9617613-2018-00075
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
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: 08/02/2018 Patient Sequence Number: 1
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