MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX UGYTEX MESH; MESH, SURGICAL, POLYMERIC

Model Number UNKPARUGYTEX

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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Cyst(s) (1800); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Discharge (2225); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Blood Loss (2597); Intermenstrual Bleeding (2665); Dysuria (2684); No Code Available (3191)

Event Date 11/08/2007

Event Type  Injury  

Manufacturer Narrative

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

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 patient underwent a mesh polypropylene cystocele repair with polypropylene midurethral sling.The pre-operative diagnosis was cystocele with stress urinary incontinence.The post-operative diagnosis was cystocele with stress urinary incontinence.The patient underwent an additional procedure on (b)(6) 2008.The procedure was a cystoscopy.The assessment was a uti.Per additional information received, the patient has experienced urinary tract infections (uti), vitamin d deficiency, and required 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, procedure name/performed cystocele repair with polypropylene midurethral sling.The patient has experienced persistent hematuria, blood with intercourse, pain with intercourse, recurrent urinary tract infections, menorrhagia with hysteroscopy, dilation and curettage and novasure endometrial ablation, vaginal odor, urge incontinence, pelvic pain, spotting between periods, bacterial vaginosis, abdominal pain, grade one cystocele, mild residual, postmenopausal atrophic vaginitis, urinary frequency, ovarian cyst, menometrorrhagia, dysuria and required medical interventions such as multiple cystoscopies, antibiotic suppression, anticholinergics, and ptsn (percutaneous tibial nerve stimulation).

Manufacturer Narrative

Exemption number: e2013003.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 cystocele with stress urinary incontinence.It was reported that after implant, the patient experienced mobility with valsalva, recurrent urinary tract infections, frequent urination and voiding small amounts, blood with intercourse, recurrent pain with intercourse (dyspareunia), recurrent cystocele with valsalva, chronic recurrent infections, recurrent vaginitis, malodorous vaginal discharge, bulky uterus, menometrorrhagia, bacterial vaginosis, persistent hematuria, dysuria, frequency, interstitial cystitis, anteverted uterus, uterus with thickened endometrium, recurrent urge incontinence, female stress incontinence, spotting since her ablation, cramping and pain, watery discharge, palpable protuberant area along anterior aspect of mid vagina never noted previously, persistent vaginal bleeding, pelvic pain, left ovarian cyst, minimally atrophic vagina, possible adenomyosis, urgency, bladder leakage, frequency and urgency which occurred after intercourse, significant bladder instability, strong detrusor contraction with very poor flow rate concerning for possible obstruction, abdominal pain, postmenopausal atrophic vaginitis, segmental dysfunction of sacroiliac region, somatic dysfunction of sacroiliac region, getting up 5-6 times per night to urinate (nocturia), and incomplete bladder emptying.She required non-surgical and surgical interventions such as bioidentical hormone replacement, antifungals for chronic candidal infections, antibiotics for recurrent urinary tract infections, anticholinergics for urge incontinence, ct of abdomen and cystoscopies for persistent hemat uria, and percutaneous tibial nerve stimulation treatments for urge incontinence; hysteroscopy, dilation and curettage and novasure ablation for menorrhagia, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

Exemption number: e2013003.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 cystocele with stress urinary incontinence.It was reported that after implant, the patient experienced mobility with valsalva, recurrent urinary tract infections, frequent urination and voiding small amounts, blood with intercourse, recurrent pain with intercourse (dyspareunia), recurrent cystocele with valsalva, chronic recurrent infections, recurrent vaginitis, malodorous vaginal discharge, bulky uterus, menometrorrhagia, bacterial vaginosis, persistent hematuria, dysuria, frequency, interstitial cystitis, anteverted uterus, uterus with thickened endometrium, recurrent urge incontinence, female stress incontinence, spotting since her ablation, cramping and pain, watery discharge, palpable protuberant area along anterior aspect of mid vagina never noted previously, persistent vaginal bleeding, pelvic pain, left ovarian cyst, minimally atrophic vagina, possible adenomyosis, urgency, bladder leakage, frequency and urgency which occurred after intercourse, significant bladder instability, strong detrusor contraction with very poor flow rate concerning for possible obstruction, abdominal pain, postmenopausal atrophic vaginitis, segmental dysfunction of sacroiliac region, somatic dysfunction of sacroiliac region, getting up 5-6 times per night to urinate (nocturia), and incomplete bladder emptying.She required non-surgical and surgical interventions such as bioidentical hormone replacement, antifungals for chronic candidal infections, antibiotics for recurrent urinary tract infections, anticholinergics for urge incontinence, ct of abdomen and cystoscopies for persistent hemat uria, and percutaneous tibial nerve stimulation treatments for urge incontinence; hysteroscopy, dilation and curettage and novasure ablation for menorrhagia, and required additional surgical and non-surgical interventions.

• Brand Name: UNKNOWN PARIETEX UGYTEX MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: lisa hernandez ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6258688
• MDR Text Key: 65028423
• Report Number: 9615742-2017-00011
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKPARUGYTEX
• Device Catalogue Number: UNKPARUGYTEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: 12/21/2016; 08/10/2018; 10/16/2018
• Supplement Dates FDA Received: 01/03/2018; 08/10/2018; 10/16/2018
• 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): Other; Required Intervention
• Patient Age: 47 YR