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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 482027
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Incontinence (1928); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discharge (2225); Urinary Frequency (2275); Injury (2348); Disability (2371); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment. Product was used for therapeutic treatment. The indication for implantation of transvaginal mesh in this patient is urinary stress incontinence. The postoperative complications that this patient developed following transvaginal placement of surgical mesh. In 2002: underwent transvaginal bladder sling procedure (with pelvicol) under general anesthesia. Complications post (pelvicol) implantation: in 2002: had bladder sling shifted, vaginal bleeding during intercourse, constipation, abnormal menses, vaginal dryness and discharge. Assessed with bladder suspension. In 2002: had previous urinary stress incontinence procedure that seemed to fail after the patient had fallen. Assessed with urinary stress incontinence. Scheduled for transvaginal bladder sling (indirect information taken from the operative report dated (b)(6) 2002) additional implant (with pelvicol) surgery details: 2002: underwent transvaginal bladder sling (with pelvicol) for urinary stress incontinence under general anesthesia. Complications post additional mesh implant surgery: (interim medical records from 2002 ¿ 2005 were not available for review) as on 2005: had urgency incontinence and urinary frequency. Scheduled for cystoscopy, urethral dilation, and removal of suture conditions post interventional surgery: had vaginal pain, painful intercourse, urinary tract infection (corresponding medical records were not available to substantiate these complications) mesh revision surgery: (b)(6) 2013: had vaginal pain and dyspareunia; pelvic mesh was removed in (b)(6) 2013 by dr. (b)(6) at (b)(6) hospital because patient was in a lot of pain and was experiencing painful intercourse but records further to (b)(6) 2005 were not available to substantiate these complications.

 
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 Key7745158
MDR Text Key115900206
Report Number9617613-2018-00076
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
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 10/04/2018
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 HEALTH PROFESSIONAL
Device MODEL Number482027
Device Catalogue Number482027
Device LOT Number01A11B520079
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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