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

Model Number UNKNOWN UGYTEX

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Discomfort (2330); Injury (2348); No Code Available (3191)

Event Date 05/18/2007

Event Type  Injury  

Manufacturer Narrative

(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 an a+p repair, both with a mesh graft placement and bilateral sacropinous ligament fixation and ileo-coccygeral vaginal vault suspension and enterocele repair and tot, and cystoscopy and perineoplasty.The preoperative and postoperative diagnosis was grade ii rectocele, grade ii cystocele.Vaginal vault prolapse, paravaginal defect, enterocele, poor perineal body support, stress urinary incontinence, and intrinsic sphincter deficiency.On (b)(6) 2007 the patient presented with a uti.She had some aches and pains and twinges here and there.On (b)(6) 2007 the patient said she had some discomfort at the introital area.On (b)(6) 2007 the patient presented for a follow up with some dyspareunia and vaginal pain.On (b)(6) 2009 the patient was referred to a doctor regarding dyspareunia, pain, and swelling in a prior surgical site.On (b)(6) 2009 the patient underwent a cystoscopy x2 and transvaginal excision of foreign body per vagina.The preoperative and postoperative diagnosis was foreign body erosion into vagina status post prior transobturator tape sling.

Manufacturer Narrative

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

Manufacturer Narrative

Relevant history and event description updated medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of a&p repair.It was reported that after implant, the patient experienced urinary tract infection, discomfort at the introital area, some tenderness on the right introit area, dyspareunia, vaginal pain, swelling, foreign body erosion into vagina the patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-op and post-op diagnosis: grade ii rectocele, grade ii cystocele.Vaginal vault prolapse, paravaginal defect, enterocele, poor perineal body support, stress urinary incontinence, intrinsic sphincter deficiency.Name of procedure: patient underwent an a+p repair, both with vaulta graft placement and bilateral sacropinous ligament fixation andileo-coccygeral vaginal vault suspension and enterocele repair and tot, cystoscopy and perineoplasty.On (b)(6) 2007 - patient underwent urodynamics and limited pelvic ultrasound, which showed she had ovarian cysts.(non-covidien)devise used: gynecare monitor system.On (b)(6) 2007 - urinary tract infection.On (b)(6) 2007 - discomfort at the introital area, some tenderness on the right introit area.On (b)(6) 2007 - dyspareunia and vaginal pain.On (b)(6) 2007 - pain in left side near the vaginal introitus and the vagina.On (b)(6) 2009 - dyspareunia, pain and swelling.On (b)(6) 2009 - patient underwent previous operation for cystoscopy x2, transvaginal excision of foreign body per vagina and than pre-op and post-op diagnosis: foreign body erosion into vagina, status post prior transobturator tape sling.Past surgical history: 1973 - tubes tied.1981 - hysterectomy 25 years ago, partial for dysfunctional uterine bleeding with tah.Past medical history: vaginal deliveries x2, hypertension, arthritis, disk disease of the back and migraine headaches.Concomitant therapy: (see ftr# (b)(4) for unknown ugytex).

• Brand Name: UNKNOWN UGYTEX MESH PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• MDR Report Key: 6186013
• MDR Text Key: 62743724
• Report Number: 9615742-2016-00210
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

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 Model Number: UNKNOWN UGYTEX
• Device Catalogue Number: UNKNOWN UGYTEX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: 11/23/2016; 11/23/2016
• Supplement Dates FDA Received: 08/29/2018; 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MESH (B)(6) 2007; MESH
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73