MAUDE Adverse Event Report: ETHICON SARL GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Total number of events ¿ 200.Gynecare prolift +m anterior pelvic floor repair system ¿ 14.Gynecare prolift +m pelvic floor repair system ¿ 3.Gynecare prolift +m posterior pelvic floor repair system ¿ 8.Gynecare prolift +m total pelvic floor repair system ¿ 13.Gynecare prolift anterior pelvic floor repair system ¿ 34.Gynecare prolift pelvic floor repair system ¿ 41.Gynecare prolift posterior pelvic floor repair system ¿ 20.Gynecare prolift total pelvic floor repair system ¿ 48.Gynecare prosima pelvic floor repair system ¿ 20.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 concurrently with total vaginal hysterectomy, bilateral salpingo-oophorectomy, mccall¿s culdoplasty and uterosacral vault suspension and the mesh was implanted due to uterovaginal prolapse, cystocele, rectocele and urinary incontinence.Following the procedure, the patient experienced dyspareunia and urinary incontinence.It was reported that the patient underwent a mesh removal on (b)(6) 2015.No further information is available.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Date sent to the fda: 04/20/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to the fda: 06/28/2017.Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Patient codes: (b)(4) device codes: (b)(4) ethicon mdr summary reporting exemption (b)(4) reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2016 through (b)(6) 2016 supplemental 06 - attachment: [(b)(6) 2016 otp supplemental 06.Xlsx].

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2016 through (b)(4) 2016.

Manufacturer Narrative

Date sent to fda: 12/27/2018.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 02/12/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 04/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

Manufacturer Narrative

Date sent to fda: 04/19/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2016 through november 30, 2016.

• Brand Name: GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• MDR Report Key: 6193920
• MDR Text Key: 62959488
• Report Number: 2210968-2016-34409
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3010361
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/02/2016; 09/02/2016; 09/02/2016; 09/02/2016; 09/02/2016; 09/02/2016; 09/02/2016; 10/25/2018; 12/27/2018; 02/12/2019; 04/24/2019; 04/19/2021
• Supplement Dates FDA Received: 02/24/2017; 04/20/2017; 06/28/2017; 08/29/2017; 10/24/2017; 12/27/2017; 02/22/2018; 04/12/2018; 06/22/2018; 08/16/2018; 10/26/2018; 12/27/2018; 02/12/2019; 04/24/2019; 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR