MAUDE Adverse Event Report: SOFRADIM PRODUCTION URETEX SUPPORT PP KIT X1; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number URETEXSUP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Micturition Urgency (1871); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Hot Flashes/Flushes (2153); Discharge (2225); Urinary Frequency (2275); Discomfort (2330); Injury (2348); Malaise (2359); Depression (2361); Fungal Infection (2419); Palpitations (2467); Prolapse (2475); Blood Loss (2597); Dysuria (2684); Constipation (3274)

Event Date 11/10/2003

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, on an unknown date in 2003, the patient underwent sacrospinous vault fixation and rectocele repair with minimally invasive mid-urethral sling placement.The patient is reportedly experiencing urinary frequency, chronic pelvic pain, recurrent second to third degree enterocele and second degree uterine prolapse.She also has symptoms consistent with interstitial cystitis.On (b)(6) 2005, the patient underwent cystoscopy, hydrodistention, bladder biopsy with bladder instillation, laparoscopic lysis of adhesions, laparoscopic assisted vaginal hysterectomy, right salpingo-oophorectomy, and enterocele repair to rule out interstitial cystitis, chronic pelvic pain, urinary frequency, history of endometriosis, recurrent pelvic organ prolapse, pelvic adhesions and right adnexal mass under general endotracheal anesthesia.The patient continued to experience worsened pain and recurrent rectocele.On (b)(6) 2006, she underwent laparoscopic diagnostic, rectocele repair with prolift mesh for chronic right lower quadrant pain, recurrent rectocele, and right lower quadrant adhesions under general anesthesia.The patient then complained of slight white discharge with odor, increased bleeding, sudden intense burning going towards rectum, infection from her surgery and now she is vomiting and unable to keep anything down.On (b)(6) 2006, the surgeon performed a laparoscopic lysis of adhesions and laparoscopic left salpingo-oophorectomy for persistent and enlarging pelvic mass under general endotracheal anesthesia.The patient complained of something happening with the rectocele - sharp shooting pain off and on, sudden onset of rectal pain after bowel movement, bulging with pain, nausea, vomiting after eating, feeling of having a urinary tract infection.She stated intense pain in vagina at rectum.The doctor diagnosed her with recurrent pelvic organ prolapse, pelvic pain, perineocele, and dyspareunia with suspected secondary adhesions from the mesh.The final procedure was performed on (b)(6) 2009 in which she underwent excision of posterior vaginal wall mesh, enterocele repair, rectocele repair with veritas graft insertion and cystoscopy for vaginal pain, dyspareunia, rectocele, perineocele, and weak rectovaginal tissue under general endotracheal anesthesia.

Manufacturer Narrative

(b)(4).

Event Description

The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced discomfort while urinating, abdominal pain, fatigue, nausea, vomiting, urinary tract infection, bladder pain/fullness, lower back/flank/hips pain, suprapubic tenderness, backache, acute cystitis (inflammation), kidney stones, burning on urination, urgency (urinary urgency), discomfort when urinating, pain with urinating (dysuria), difficulty urinating, difficulty emptying bladder, loss of appetite, urinary frequency, urinary difficulties, malaise, fatigue, pelvic pressure, burning to rectum, ovarian cyst, discharge, infection, pelvic/vaginal/rectal pain, recurrence of rectocele (prolapse), adhesions, blood loss, enlarging pelvic mass, candida (fungal infection), interstitial cystitis (inflammation), pelvic organ/uterine prolapse, urinary frequency, scarring, enterocele defect (prolapse), lower quadrant pain, irritation, coronary spasms (muscle spasms), tenderness, bulging, discomfort, depression, palpitations, hot flashes, difficulty starting urine, perineocele, dyspareunia, impaction, difficulty emptying bladder, bladder pain, delay before urination, strain to urinate, stop/start while urinating, constipation, foreign body giant cell reaction, inflammation, organizing granulation tissue, fibroids, focal microcalcification (calcification),weak/thin rectovaginal tissue, thin/attenuated peritoneal body, visible/palpable mesh, scar tissue, enterocele, and required nonsurgical and additional surgical interventions.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, the patient has experienced left sided ovarian pain, pelvic pressure, intense burning going toward rectum, white [vaginal] discharge, bleeding, recurrent urinary tract infections, vaginal and rectal pain, second degree uterine prolapse, second to third degree enterocele, discomfort with urination, abdominal pain, bladder pain, fullness, lower back pain, acute cystitis, urgency, frequency, dysuria, difficulty emptying bladder, flank pain, burning with urination, yellow vaginal discharge, tender thickening posteriorly secondary to mesh, apical adhesions, large perineocele, rectocele, impaction, erosion, extrusion, bowel problems, recurrence, bleeding, dyspareunia, neuromuscular problems, weak rectovaginal tissue and vaginal scarring.She underwent several procedures including cystoscopy, hydrodistention and bladder biopsy, bladder instillation, laparoscopic lysis of adhesions, laparoscopically assisted vaginal hysterectomy, right salpingo-oophorectomy, enterocele repair, johnson and johnson system prolift posterior pelvic floor repair gynecare, recurrent rectocele, excision of posterior vaginal wall mesh, placement of veritas mesh.

• Brand Name: URETEX SUPPORT PP KIT X1
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5813357
• MDR Text Key: 50137717
• Report Number: 9615742-2016-00094
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Model Number: URETEXSUP
• Device Catalogue Number: URETEXSUP
• Device Lot Number: C23188SUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR