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

Model Number UNKPARUGYTEX

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

Patient Problems Micturition Urgency (1871); Incontinence (1928); Itching Sensation (1943); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Incident date was not provided.Lot number not provided.Udi not provided.Re-processing information not provided.Date received by mfr: since the lot number was not provided, this information cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.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.The preoperative and postoperative diagnosis was uterovaginal prolapse large cystocele and stress urinary incontinence.The procedure performed was an anterior mesh repair, colpopexy; transobturator tape suburethral sling, and cystoscopy.A physical examination shows moderate cystocele and good symptomatic relief from stress urinary incontinence on (b)(6) 2006.On (b)(6) 2008 a physical examination shows that sling is palpable.The patient was assessed with a symptomatic cystocele.On (b)(6) 2012 the patient complained of severe vaginal itching.The patient was assessed with vulvar pruritus.She was scheduled for vulvar biopsy.Between (b)(6) 2012 the patient still had vulvar itching.A vulvar biopsy was done on (b)(6) 2012 and she was assessed with vulvar pruritus lichen sclerosis.On (b)(6) 2013 the patient complained of vaginal itching and urgency.Physical examination shows vagina revealed cystocele and rectocele.On (b)(6) 2014 the patient complained of urinary incontinence and dysuria.The patient stated her exercise level was moderate and frequency was occasional.The physical examination showed cystocele, sling palpable, anduterus - grade i prolapse.She was assessed with cystocele without prolapse.Between (b)(6) 2015 the patient complained of mixed incontinence, had urge to urinate, bulge in vagina, urgency, difficulty emptying bladder, nocturia (10 per night), and urinary frequency.Her urge incontinence began 1 year ago.She leaked urine when she coughed, laughed, sneezed or bears down.Her symptoms had gotten worse over the last year.She did wear protective pads.She was having problems with emptying her bladder as well.The onset of rectal incontinence had been occurring in an intermittent pattern for 1 year.There had been associated stool leakage.The physical examination showed large cystocele at the vaginal introitus and anterior scarring with mesh.

Manufacturer Narrative

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

• Brand Name: UNKNOWN PARIETEX UGYTEX MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6394927
• MDR Text Key: 69624036
• Report Number: 9615742-2017-05041
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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
• Date Manufacturer Received: 02/08/2017
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: MONARCH SUBURETHRAL SLING.
• Patient Outcome(s): Other
• Patient Weight: 96