MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number URETEXSUP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Incontinence (1928); Inflammation (1932); Device Overstimulation of Tissue (1991); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Injury (2348); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Blood Loss (2597); Foreign Body In Patient (2687); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Exemption number: (b)(4) medtronic is submitting this report on behalf of c.R.Bard, inc (importer) c.R bard reference number: (b)(4).Uf/importer report number: (b)(4).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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Reason for mesh implantation: stress urinary incontinence, cystourethrocele with bilateral paravaginal defects, rectocele, chronic constipation procedure (s) performed: uretex suburethral tension free sling, cystoscopy, bilateral paravaginal repairs and posterior repair and enterocele repair using pelvicol, lysis of adhesions, laparoscopic uterosacral colpopexy concomitant devices: bard ® pelvicol acellular collagen matrix 04b16-1 (lot no.) 482068 (reorder no.) bard ® pelvicol acellular collagen matrix 04b04-2 (lot no.) 482412 (reorder no.) uretex sup d24292sup (lot no.) 485013 complications post pelvicol and uretex implantation: (interim medical records from (b)(6) 2005 to (b)(6) 2011 are not available for review) (b)(6) 2011 ¿ (b)(6) 2011: stress urinary incontinence, urinary retention.Patient leaks day and night, pan with intercourse and has leakage with intercourse.Pvr 475 ml with positive dip stick.Urine culture revealed escherichia coli.Diagnosed as incomplete bladder emptying, cystitis, urinary incontinence.Prescribed bactrim ds (b)(6) 2011 ¿ (b)(6) 2011: stress urinary incontinence, nocturia 5 to 6 times, incomplete bladder emptying, on examination cam palpate the sling edge in the right fornix and to a lesser extent in the left fornix periurethrally.Urine culture revealed enterococcus species.Diagnosed as overactive bladder, recurrent urinary tract infections, burning with urination.Planned for ureterolysis and prescribed macrobid for 5 days, monistat for 7 days (b)(6) 2012 ¿ (b)(6) 2012: leaks with urgency, nocturia 3 to 5 times, burning and stinging, pain with voiding, she woke multiple times overnight to void.On examination palpate part of the sling periurethrally on her right.She is more tender periurethrally on her left.Urine culture revealed pseudomonas aeruginosa.Diagnosed as chronic cystitis, overactive bladder incomplete bladder emptying.Planned for urethrolysis and cystoscopy, prescribed cipro 250 mg first mesh revision surgery (uretex sup): (b)(6) 2012: underwent urethrolysis and cystoscopy for bladder lesion history of urinary tract infection, incomplete bladder emptying, status post placement of uritex (must be uretex) suburethral sling under general endotracheal anesthesia.Following the mesh revision surgery, she developed serious complications that required additional surgeries.Complications includes vaginal bleeding, pelvic pain, bladder neck and urethral obstruction with foreign body (vaginal mesh) in vagina, incomplete bladder emptying, stress urinary incontinence, vaginal atrophy ¿ bulking therapy using coaptite under local nitrous analgesia, periurethral scarring, retropubic scarring during the interim period (b)(6) 2012 ¿ (b)(6) 2015 for which she had undergone following additional surgeries.First additional surgery: (b)(6) 2012: underwent rigid cystoscopy, bladder biopsy and fulguration for diffuse bladder lesions under local monitored care anesthesia (mac) second mesh revision surgery (uretex sup): (b)(6) 2012: underwent urethrolysis, removal of vaginal mesh, cystoscopy for bladder neck and urethral obstruction with foreign body (vaginal mesh) in vagina under general anesthesia second additional surgery: (b)(6) 2013: underwent cystotomy with cystostomy catheter drainage for incomplete bladder emptying under general anesthesia.Additional implant surgery (using fascia lata graft): (b)(6) 2015: underwent pubovaginal sling using rectus fascia, urethrolysis for stress urinary incontinence, periurethral scarring, retropubic scarring under general anesthesia.

Manufacturer Narrative

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

• Brand Name: MESH SOFRADIM - URETEX
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7670070
• MDR Text Key: 113512582
• Report Number: 9615742-2018-01504
• 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
• Report Date: 10/05/2018

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 Expiration Date: 10/31/2009
• Device Model Number: URETEXSUP
• Device Catalogue Number: URETEXSUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2012
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• Date Device Manufactured: 10/01/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR