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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 Erosion (1750); Incontinence (1928); Inflammation (1932); Abnormal Vaginal Discharge (2123); Discomfort (2330); Injury (2348); Blood Loss (2597); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

Manufacturer reference number: (b)(4). Incident date was not provided. Lot number not provided. Udi not provided. Re-processing information not provided. Since the lot number was not provided, this information cannot be determined.

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The indication for implantation was uterine procedentia with international continence society, stage iv cystocele, international continence society stage iv posterior vaginal vault prolapse, rectocele, enterocele, and urodynamic stress incontinence with urethral hypermobility. The procedure performed was a total abdominal hysterectomy with bilateral salpingooophorectomy and burch retropubic urethropexy for her uterine prolapse as well as stress urinary incontinence and urethral hypermobility, abdominal sacrocolpopexy utilizing soft prolene mesh in a retroperitoneal graft approach for her vaginal vault prolapse, paravaginal defect repair for her cystocele, extending well above the urethrovesical junction, abdominal repair of enterocele with retroperitoneal graft approach, vaginal rectocele repair utilizing xenograft mesh with soft prolene mesh as well, cystoscopy with suprapubic tube placement. Between (b)(6) 2007 the patient experienced bowel gas discomfort, minimal discharge, moderate discomfort, intermittent post void dribbling, and dyspareunia. Between (b)(6) 2008 the patient experienced intermittent pelvic bleeding, increased discharge, bleeding from vagina from bowel movement, and rare straining. On (b)(6) 2009 the patient experienced bladder leakage, strain for bowels, experience urine leaking related to cough, sneezing or laughing, and mesh exposure. On (b)(6) 2009 the patient experienced mesh exposure. On (b)(6) 2013 the patient underwent an excision of posterior vaginal mesh for posterior vaginal wall mesh erosion under general anesthesia. The preoperative and postoperative diagnosis was posterior vaginal wall mesh erosion. Following mesh revision surgery, she developed complications such as mild constipation, minimal discharge, discomfort, mixed incontinence, postmenopausal atrophic vaginitis, intrinsic urethral sphincter deficiency, muscle atrophy during the interim period (b)(6) 2009 to (b)(6) 2015 and did not undergo any additional surgery.

 
Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code. 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 avenue
north haven, CT 06473
2034925563
MDR Report Key6395390
MDR Text Key69630767
Report Number9617613-2017-05033
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
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
Device LOT Number06B04-9
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 Received03/09/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/10/2017 Patient Sequence Number: 1
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